Product was distributed to:  CA, KS, KY, MN, and MO.
BAYER Spectam Injectable (spectinomycin) 100 mg/ml, packaged in 500 ml rubber-stopped glass bottles, Net Contents:  500 ml (NDC 0859-2383-01), NADA 040-040. The responsible name on the firm is Bayer HealthCare, Shawnee Mission, KS 66201.  Product of China.
Product did not meet stability specifications; an out of specification result was reported for a known impurity at the 6 month time point.
Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial  ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1  An intraoperative image-guided localization system to enable minimally invasive surgery.
Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM;  19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL.       Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)
12 systems total (10 in U.S., 2 in Australia)
Instances of data sets not being accurately registered to the patient anatomy were observed.
ErgoSafe Products, LLC (DBA) Prism Medical
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg.   Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use
Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Italian Green Beans. Product is IQF frozen, not ready to eat, each label carries cooking instructions.     Packages sizes: 14 oz.; 16 oz.; 2 lbs.; 2.5 lbs.; 20 lbs. and 1,350 lbs. (tote)    Product is sold under brands: Birds Eye (C&W), Markson First Crop, Bountiful Harvest, River Valley, Simplot Classic, Sysco Classic, Sysco Imperial, National, Monarch, Valamont, Worlds Finest, Tasteful and totes .    Labels read in part:   Item # 70332-00052 (not on label).    ''***BIRDS EYE C&W ***cut italian green beans***14oz***(UPC) 0 70332 00052 8***'' Proof, of bag label. provided. Shipper case UPC Code 10070332000525.    Item # 23234-13195 (not on label).    ''***12/2 LB***334400***MARKSON FIRST CROP*** Case label and proof of generic bag label provided.  Generic labels are stamped with Net Wt. during production. No UPC Code - Generic Bag; Shipper Case UPC Code 10723234131957.    Item # 22486-11893 is contained on case label  ''***12/2.5 LB BAGS NET WT. 30 LBS***22486***11893***1614***Bountiful Harvest Originals ITALIAN GREEN BEANS******''  Case label and bag label provided.  No UPC Code - Generic Bag.  Shipping Case UPC Code 30822486118939.    Item # 78982-00445-2 not on bag.  ''*** RIVER VALLEY*** Italian Green Beans NET WT. 16 OZ.***(UPC) 0 78982 11445 2***''. Bag label provided.  Shipping Case UPC Code 78982114452.    Item # 71179-18052 not on bag/box.  ''***12/32 OZ BAGS***10071179180524***SIMPLOT CLASSIC ITALIAN BEANS***''.  Case label and a generic Simplot proof label for bag provided. There is no UPC on generic bag; Shipping Case UPC Code 10071179180524.    Item # 74865-07851 not on label.    ''***Classic SYSCO ***Italian Cut Green Beans*** NET WT 32 OZ (2 LBS)***''.  Proof of bag and case label provided.  No UPC Code-Generic Bag. Shipping Case UPC Code 1007117918052.    Item # 74865-38722  ''*** Imperial SYSCO ***FRESH FROZEN ITALIAN BEANS 6409577***'' 12/2 LB. stamps applied, case and partial copy of bag labels provided. UPC for bag 74865-38722, Shipping Case UPC Code 10074865387221.    Item # 74865-07851  '
Italian Green Beans product is recalled due to potential to be contaminated with Listeria monocytogenes.
Italian Blend. Product is IQF frozen, not ready to eat, each label carries cooking instruction.     Label reads in part:  ''*** market pantry *** STEAM-IN-BAG Italian-Style Blend Broccoli, Cauliflower, Carrots, Italian-Style Green Beans & Zucchini*** NET WT 12 OZ***(UPC) 0 85239 90084 0***''  Shipper Case UPC Code 10085239000847.    Proof of bag label provided.  This product is produced solely for Target stores.
Italian Blend product is recalled due to potential to be contaminated with Listeria monocytogenes.
Italian Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   ''***FIRST STREET***ITALIAN BLEND CARROTS, CAULIFLOWER, ITALIAN GREEN BEANS, ZUCCHINI, LIMA BEANS*** NET WT 32 OZ***''    UPC on bag 041512081958; Shipping Case UPC Code 47203.  Copy of photo of bag label provided.
Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes.
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   ''***SIMPLOT CLASSIC*** ITALIAN BLEND*** INGREDIENTS:  ZUCCHINI, CARROTS, CAULIFLOWER, ITALIAN BEANS, LIMA BEANS, RED BELL PEPPER***''      For 12/2 lb UPC on proof for bag 0 71179 18875 2. Shipping Case UPC Code 10071179188759.    For 20 lb. case, a blue liner is used (no UPC), Shipping Case UPC Code 10071179188872.    20 LBS. NET WT case consists of one unmarked blue poly bag.  32oz (2 LBS) - case consists of 12/32oz packages    Copy of proof for bag and proof for case label provided.
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   ''***Sysco Classic Italian Vegetable Blend***NET WT***2 LB***INGREDIENTS:  Zucchini, Carrots, Cauliflower, Italian Green Beans, Baby Lima Beans***UPC 0 74865 01802 9***''  Shipping Case UPC Code 10084765018026.    Case label reads in part  ''***Sysco Imperial ITALIAN VEGETABLE BLEND***6/4 lb***INGREDIENTS:  Zucchini, Carrots, Cauliflower Florets, Italian Beans, Lima Beans***''  No UPC Code on inner generic bag; Shipping Case UPC Code 10074865024447.
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   Item # 58108-03475  ''***MONARCH***ITALIAN VEGETABLE BLEND CONTAINS ZUCCHINI, CARROTS, CAULIFLOWER, LIMA BEANS AND ITALIAN GREEN BEANS***NET WT***64 OZ***(UPC) 7 58108 03475 4***''  Copy of photo of bag label provided.  Product is packaged as 6/4 lb bags.  Shipping Case UPC Code 5075808034759.    Item # 72608-13991  ''***12/2 LBS***72608***13991***VALMONT ITALIAN BLEND CONTAINS:  ZUCCHINI, CARROTS, CAULIFLOWER, LIMA BEANS, ITALIAN BEANS***''  Shipping UPC Case Code 1 00 72608 13991 5.  Copy of case label provided.
Monarch 72,696 lbs or 3,029 cs (6/4lb); Valmont 874 cases or 20,904 lbs
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   ''***MARKON FIRST CROP***  A proof of the label was provided, it does not contain product identity, net wt or ingredients.    This product is available in two sizes, 12/2 lb or 20 lb. Copies of case labels were provided.  Label reads in part  ''***20 KB NET WT. 349548 MARKON FIRST CROP ***ITALIAN BLEND CONTAINS:  BROCCOLI, CAULIFLOWER, CARROTS, ITALIAN BEANS, LIMA BEANS,***(UPC) 0 07 23234 13245 2***''  No UPC on blue liner.  Shipping Case UPC Code 10723234132954.    ''***12/2 lbs 349547 MARKON FIRST CROP***ITALIAN BLEND CONTAINS:  BROCCOLI, CAULIFLOWER, CARROTS, ITALIAN BEANS, LIMA BEANS***''  No UPC on generic bags; Shipping Case UPC Code 10723234132954.
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part   ''***GARDEN FRESH***64775***47374***ITALIAN BLEND CONTAINS:  ZUCCHINI, CARROTS, CAULIFLOWER, LIMAS, ITALIAN BEANS***20 LB NET WT***''  No UPC on blue liner.  Shipping Case UPC Code 6477547374.    Product of (Country or Countries) is stamped on the case at the time of production.  A label example stated product of USA/China.    Photo of case label provided.
Italian Vegetable Blend.  Product is frozen, not ready to eat, label carries cooking instruction.     Label reads in part  Case''***Sysco Imperial ***FIESTA VEGETABLE BLEND***REORDER# ***8446007 *** 6/4 lb*** (UPC) 1 00 74865 52887 7***INGREDIENTS:  Broccoli, Carrots, White Beans, Red Kidney Beans, Italian Beans, Garbanzo Beans, Red Peppers***''    The inner bags are generic with no UPC code.
Lot Code Information   Item # 74865-02444 - 29748-4K07G3N and 30565-5A28K3N with corresponding expiration dates 10/7/2016 and 1/28/2017.
Cold Smoked Salmon Deli trays (CS300), 2 pcs, 3lbs/trays.  6lbs per case.
Certified Smoked Fish is Cold Smoked Salmon because they have the potential to be contaminated with Listeria monocytogenes.
Cold Smoked Salmon Trim (CST50), 2 pcs, 2.5 lbs/case.  5lbs per case.
Nationwide Distribution, District of Columbia, and Puerto Rico.
Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL.   The HomeChoice and HomeChoice Pro APD systems are intended to be operated by:    -Home patients whose physicians have prescribed this system. Patients, or  their caregivers, must have received adequate training to use the system.    -Clinicians who are using the system for patients under their care and  under a prescription. Clinicians must have received adequate training to  use the system.    Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins.
All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R.    Dates Distributed: 1994 to present   Quantity Distributed: All
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it.  May delay treatment if changing to a different system.
LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Frozen Peas & Carrots, Product is IQF, frozen, not ready to eat, each label carries cooking instructions.  Product is packaged under the following brand names and sizes:   1.  Bountiful Harvest, Net Wt.40 oz. (2.5 lbs.) 1.13 kg, UPC 22486-11902;   2.  Giant Eagle, Net Wt 16 oz (1 lb) 454 g, UPC 30034-00993;   3.  Our Family, Net Wt 16 oz (454 g), UPC 70253-10513;   4.  Sysco Classic, Net Wt 40 oz (2.5 lbs) 1.13 kg, UPC 74865-07850.
Bountiful Harvest:  Packaging Code:  PL25132 / Production Code:  1086893;   Giant Eagle:  Packaging Code:  PL25125 / Production Code:  1086893  Best By 05/2014;     Our Family:  Packaging Code:  PL35132 or PL45132 / Production Code:  1086893, Best By 05/2017  Sysco Classic:  Packaging Code:  PL25148 / Production Code:  PLMB4305, Best By 05/2017
The Ohio Department of Agriculture conducted testing on the product and found it positive for Listeria monocytogenes.
Cucumber, Super Select Unspecified variety packed in Hello Fresh box the week of August 24-28-2015 in the meal Spicy Tuna Tar-Tacos with Creamy Avocado and Cucumber Radish Slaw. 7-10 inches long, I cucumber per box.
Firm was notified by their supplier that cucumbers provided are under recall due to potential Salmonella contamination.
Cucumber, sliced 3/8'', product is packaged in a 2 lbs. plastic bag and placed in a cardboard box.   Product is sold to deli department at retail store and it is not sold directly to consumers. The UPC is 0 45009 10104 4.
Cucumber, sliced 3/8'', is recalled due to a potential contamination with Salmonella.  Sliced cucumber is linked to the current recall of Limited Edition Brand Cucumbers being conducted by Andrew & Williamson Fresh Produce.
Raw cucumbers packaged in bulk in 6-count corrugated boxes bearing the Front Row Produce logo.  There is no city or state listed on the label.
CU-W-Whole Cucumbers (1/6 CT Bag) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Whole Cucumbers 1/5-LB NET WT: 5 LB Distributed by: US Foods, Inc. Rosemont, IL 60018 PRODUCE OF USA & MEXICO
Potential to be contaminated with Salmonella.
SK-TG-Timeless Garden Salad Kit (1/2.43 LB) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160
Sliced Cucumbers (100/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Sliced Cucumbers (50/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; CU-2-Sliced Cucumbers (1/5 LB Tub) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160
Taboli Net Wt. 80 oz (5 lb/2.82 kg) KEEP REFRIGERATED Manufactured by Fresh Creative Foods, Inc. Moore, OK 73160 in plastic tub
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx  only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL  Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
Dapiprazole (Diluent+Powder)  0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99
Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06
Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02
ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use  Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07
Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50
Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe,  For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06
L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07
MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07
Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.
Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07
MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.
MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.
Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02
Neostigmine (5 mg/5 mL),  5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01
Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.
Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper  For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07
Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07
Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
Triamcinolone diacetate USP PF (40 mg/mL),  2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle  For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
Zinc Sulfate  (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC  62295-3226-07
ND, IL, CA, NV, CO, OK, TX, IA and Canada
Fat Boy Fresh Produce - cucumbers. Cucumbers are often referred to as Slicer or American cucumber and are 7-10 inches long ang 1.75 to 2.5 inches in diameter.    Sold in cartons containing 24,cucumbers ;  6 cucumbers and  5 lbs of cucumbers.   Additionally Super Select Fat Boy Label cucumbers are sold in cartons of 72 and in Reusable Plastic Containers of 65-75 count..    Distributed by Custom Produce Sales, Parlier, CA.
Fat Boy lot Codes: 93968, 94506, 94550, 94522, 94513, 93991.   Reusable Plastic Containers (RPC) - Super Select label on container. Lot Code:  (01) 1 0851821 22000 2 (10) 99  Item #  552678329.
2175 cartons Fat Boy Label, 1200 RPC containers and 199 Cartons of Fat Boy to Canada
Cucumbers received from direct supplier and currently under recall for potential Salmonella contamination were repacked and distributed under a different brand name..
PROVA, Standard Exhausted Vanilla Seeds, Graines VRAC, Caisses-outres of 50 X Lbs, packaged in a cardboard box.
Potential for the food to contain small pieces of metal.
Semi-Sweet Chocolate mini chips packaged in a plastic bad with yellow label and white lettering.
Packages of Semi-sweet chocolate mini chips may contain undeclared sunflower seeds, pumpkin seeds, and dried fruit from an Enjoy life foods seed and fruit mix product that was inadvertently added to the Semi-sweet chocolate mini chips product.
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Failed Impurity/Degradation Specifications:  Out of Specifications result obtained for a known impurity.
Blood product, collected from a donor who disclosed travel history to a malarial endemic area, was distributed.
Blood products, collected from a donor who disclosed travel history to a malarial endemic area, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c)  6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery.  Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
The firm decided to recall the product due to receiving complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
American National Red Cross, Penn Jersey Region
Misbranded red blood cell was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, collected from donors who resided in or traveled to an area considered endemic for malaria, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, which were not filtered according to specifications, were distributed.
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Defective Container: Product missing safety seal around the neck of the bottle.  The product label indicates, ''Tamper Evident: Do not use if printed seal around cap is broken or missing.''  Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
American Red Cross Greater Alleghenies Region
Ohio; Pennsylvania; West Virginia; District of Columbia; Virginia; Maryland
Apheresis Red Blood Cells, Leukocytes Reduced
W202715255607 (double collection); W202715255616 (double collection); W202715252819 (double collection)
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
HUA ZHI YING GOURD CANDY, 250G(8.8oz), each carton is packed with 40/250G units, An Shun Trading Co., LTD 4425B 1st AVE BROOKLYN, NY 11232 (718) 509-9558
The product was found to contain undeclared sulfites and FD&C Blue # 1 based on sampling and analysis by New York State Department of Agriculture and Markets.
Baked Brie Herb/Garlic. An 8 ounce portion of Baked Brie wrapped in Phyllo Dough with garlic and herbs.  Product shipped frozen, but sold thawed  in a cheese case.  UPC 2 17563 01499 7
SELL BY or BEST BY dates:  10/1/15 and up to 10/21/15
Baked Brie Herb/Garlic was recalled due to undeclared pecans.
Worldwide Distribution - US (nationwide) and Internationally to  AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO.   REFs 610-1215, 610-1234, 610-1235, 610-1236.     Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Sterility of the product cannot be assured.
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus  (12, 14, 16, 18GA) needle guides, Rx ONLY.      REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061.  Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus  (12, 14, 16, 18GA) needle guides, Rx ONLY.    REF 667-132.   Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
CIVCO Sales Demo Kit.   REF DEMOGPGUIDE   Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
Cyberonics Vagus Nerve Stimulation (VNS) Therapy AspireSR Generator, Model 106
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Ocean's Halo, The Seaweed Chip. Sea Salt Flavor; 2.5 oz. bag  Organic and Gluten Free ingredients.  USDA Organic.    Outer Case UPC: 10851899005174   Unit (Bag) UPC:  8 51899 00517 7    Distributed by New Frontier Foods, Inc. Burlingame, CA.
Routine tests showed levels of gluten above the FDA limit for a gluten free product.
Ocean's Halo, The Seaweed Chip. Chili Lime Flavor; 2.5 oz. bag  Organic and Gluten Free ingredients.  USDA Organic.    Outer Case UPC: 10851899005198  Unit (Bag) UPC:  8 51899 00519 1    Distributed by New Frontier Foods, Inc. Burlingame, CA.
Ocean's Halo, The Seaweed Chip. Korean BBQ Flavor; 2.5 oz. bag  Organic and Gluten Free ingredients.  USDA Organic.    Outer Case UPC: 10851899005181  Unit (Bag) UPC:  8 51899 00518 4    Distributed by New Frontier Foods, Inc. Burlingame, CA.
American Natl. Red Cross-Greater Chesapeake & Potomac Region
Misbranded red blood cells were distributed.
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
Shipped to 2 retail locations in Florida
Florida Avocado, 14 count cardboard boxes.  Invoice #5781, Sale P.O. #29899.438426.74307, Shipped Date 08/18/15
MI. KY, IN, WI, TN, CT, NY, MA, OH, MD, NJ, OH, MO.
Dole All Natural SPINACH;  Net Wt. 8 oz. (227 g).  Enjoy by 10-15-15,  UPC 7143000976  Product of the USA  Excellent Source of Vitamin A, K, C, Folate and Manganese  Distributed by Dole Fresh Vegetables, Monterey, CA
Lot code A27409B and A27409A, Enjoy by October 15, 2015.
Random Sampling by the Michigan Department of Agriculture had a positive result for Salmonella in one bag of spinach.
Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x.   Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
Nationwide Distribution including the states of  AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI.
Taut Introducers 10/BX7.5 FR 3.5, Product Code PI-93.  To provide an access port into the peritoneal cavity.
The defective component can cause gas leakage through the device.  This can result in loss of pneumoperitoneum, potentially necessitating removal  of the defective device and insertion of another device.
US distribution in retail stores in the states: NC, SC, and VA
Fresco Fresh Banana Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub.
Fresco Fresh Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub.
Fresco Fresh Strawberry Blueberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub.
Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299
Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.  In vitro diagnostic machine component.
During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.
Roche issued a voluntary recall for a single unit of the Bulk Loader Module for cobas p 512/612, due to the design of the loader making it possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Blood products, collected from inelieible donors, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
US Distribution only: LA, CA, NJ, TX, NV, MT, NE, OH, OR,  One consignee in Canada.
Classic Baklava; Net WT 5.5 lbs (2.43 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 11930  Manufactured by Kronos Foods Corporation, Madera, CA
82 cases (5 trays of 24 bundled together for one case)
Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections.
Natural Mini Caterer's Assortment Net WT 4 lbs. (1.81 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 10169  Manufactured by Kronos Foods Corporation, Madera, CA
Deluxe Assortment,  Net WT 5 lbs. (2.27 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 10922  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 10922 Lot Number 15267, Exp 3/24/16
Chocolate Almond Treasure Net WT 4  lbs. (1.81 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 10932  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 10932 Lot Number 15272, Exp 3/2916;  Lot Number 15258, Exp 3/15/16;  Lot Number 15260, Exp 3/17/16.
Baklava Sample Assortment Net WT 4  lbs. (1.82 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 10944  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 10944 Lot Number 19275, Exp 4/02/16;  Lot Number 15266, Exp 3/23/16;
Sample Assortment Net WT 4  lbs. (1.82 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 11904  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 11904 Lot Number 15268, Exp 3/25/16.
Baklava Assortment Net WT 4  lbs. (1.82 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 11604  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 11604 Lot Number 15271, Exp 3/2816.
Orange Blossom Baklava Net WT 5.5  lbs. (249 kg)  total weight of five trays bundled together.  38-68 pieces per tray  Item number 11934  Manufactured by Kronos Foods Corporation, Madera, CA
Item number 11934 Lot Number 15258, Exp 3/15/16.
US and  Japan, Virgin Islands, India, Costa Rica, Honduras, El Salvador, Nicaragua, Guatemala, Panama, Aruba, Jamaica, Barbados, Trinidad/Tobago, Dominican Republic, US Virgin Islands, Columbia, American Samoa, Curacao, Guam, Grand Cayman Islands, St. Croix, St. Marten, St. Thomas and Fiji. Shipments to Costco in Japan, and to India and Fiji, were made to a distributor, Otis McAllister, Inc., 300 Frank H. Ogawa Plaza, suite 400, Oakland, CA 94612, which then sold the product to the retailer in those countries.
Martinelli's Gold Medal Sparkling Cider, 8.4 oz glass bottles; Packed in 12 pack, UPC  0 41244 00256; item number 12256;  4/6 packs, Tray UPC 0 41244-99932 3, item number 46256;  6 pack Retail UPC  0 41244 46256 8.  Single 8.4 oz. bottle, UPC 041244 00256 6
12 pack:Best Before dates include  03/05/2018 to 04/11/2018. 6 pack Best Befroe dates include 3/02/2018 to 04/15/2018.
166,804 trays of 12 packs, 31,939 trays of 4-6 packs
Potential for glass fragments in 8.4 oz. bottles of four varieties of sparkling cider.
Martinelli's Sparkling Red Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC  0 41244 99926 2; item number 99926;  4/6 packs, Tray UPC 0 41244-64926 6, item number 64926  6 pack retail UPC 0 41244-64026 3.  Single 8.4 oz. bottle - UPC 0 41244 99026 9.
12 pack: Best Before dates include  05.28/18 to 09/04/2018. 6 pack Best Before dates include 08/31/18 to 09/11/2018.
10,983 trays of 12 packs ,    9,998 trays of 4-6 packs
Martinelli's Sparkling White Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC  0 41244 99925 5; item number 99925;  Single 8.4 oz. bottle - UPC 0 41244 99025 2.
12 pack: Best Before dates include  05/07/18 to 05/09/2018.
Martinelli's Sparkling Northwest Blend Cider ,  8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC  0 41244 99057 5; item number 99957;  Single 8.4 oz. bottle - UPC 0 41244 99057 3.
12 pack: Best Before dates include  03/20/2018 to 05/15/2018
Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.
Easy Dial Oxygen Regulator,  168708D and 168715D.   Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
It has come to our attention that the above lots of Oxygen Dial Regulators, could have the settings label off by one position. This means that when the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. The 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).
US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.
SilverStat, sterile 2'' x 2 '' calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07.         Product Usage:  SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k.  Need to remove: for haemostasis following needle/sheath removal
Blood product, for which the donor was previously deferred due to malarial history, was distributed.
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
L-Tryptophan  Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Cyanocobalamin Buffered  Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
HCG (Lyophilized) Injectable, 5000 units/vial,  5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Chromium  Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
Synthes Application Instrument for Sternal ZIPFIX.   Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
Worldwide Distribution - US (nationwide) and Internationally to Australia.
1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA  These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D  These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D;  DrugSmart 9 Test Cup (BUP), Item No. 60960D;  DrugSmart Cup 10, Item No. 61093D-3C    These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D  These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142;  iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131;  iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023;  iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013;  iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016;  iCup DX Drug Screen, Item No. I-DXA-1127-023    These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP;  Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP;  Immutest 5 panel, Item No. IMCA-5AB-W;  Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W;  Immutest 7 panel, Item No. IMCA-7P;  ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P    These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU   These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC   These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M,  PSCupA-10MO, PSCUp-10AB;  ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM;  ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX,  PSD-10M, PSD-10CMO3, PSD-10APO-300;  ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300;  ProScreen 11 Panel Dip Card, Item No. PSD-11MT;  ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU;  ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP;  ProScreen 12 Panel Dip Card, Item No. PSD-12BUP  ProScreen 5 Panel Dip Card, Item No. PSD-5MB;  ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300;  ProScreen 6 Panel Cassette w/Adult  (AU), Item No. PSPA-6MBAU;  ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU;  ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300,  PSD-6MB, PSD-6BUPO;  ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M;  ProScreen 8 Panel Dip Card, Item No. PSD-8P;  ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P;  ProScreen 9 Panel Dip Card, Item No. PSD-9P;  ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W;  ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W;  ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W;  ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W,  PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300;  ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W;    These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU),  Item No. TDDA-6MBAU-CUP    These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU  These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Philips Electronics North  America Corporation
Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Lebanon, Macau, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Yemen.
ECG Out Cable, for use with a Philips ALS  monitor/ defibrillator and bedside monitor for Synchronized cardioversion and  Transcutaneous pacing.  M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
All Philips M1783A and M5526A sync cables are affected by this issue.  The model number is printed on the outside of the cable, near the end with the  inch phone plug.
When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101.   For Use in the Preparation of acid concentrate for hemodialysis.
All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147.   For Use in the Preparation of acid concentrate for hemodialysis.
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075.   For Use in the Preparation of acid concentrate for hemodialysis.
USFX Granny Smith Apples 175ct apples. Unit Size: Case/ Cardboard Carton, SKU 0244.
Northstar Produce Inc. is recalling 98 cases of Granny Smith apples because a test performed on a sample of the apples indicated the presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli.
Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia Finland Germany Ghana Gibraltar Greece Guatemala Holland Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea Kuwait Laos Latin America Lebanon Libya Lithuania Malaysia Mexico Morocco Nepal Netherlands New Zealand Norway Pakistan Palestine Panama Peru Philippines Poland Portugal Russia Saudi Arabia Serbia Singapore South Africa Spain Sri Lanka Sudan Switzerland Syria Taiwan Thailand Turkey UAE Ukraine USA Venezuela Vietnam Yemen Zimbabwe
Inspiration Ventilator System, i Series and LS 12.1  LCD.   The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
All models manufactured prior to 2015 are affected
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Blood Centers of the Pacific - Irwin Center
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis blood products, incorrectly labeled as having an extended expiration date, were distributed.
Product was shipped to teh following states: AR, AL, AZ, CA, FL, GA, IL, IN, KY, ME, MI, MO, MS, NC, NE, NH, NY, OH, PA, TX & VA.   Product was also shipped to Canada.
Mountain Mix 2oz bag, 7oz pouch, 10oz pouch, 17oz tin, 28oz pouch & 25lb bag. INGREDIENTS: Raisins, Peanuts (Peanuts, Peanut and/or Canola Oil, Salt), Choco Buttons (Sugar, Partially Hydrogenated Vegetable Oil [Contains One or More of the Following: Palm Kernel***Produced in a facility that processes peanuts and other nuts. Sold under the brand names of Better Valu, Clear Value, Favorite, King's & Valu Time.
KING'S MOUNTAIN MIX 2 OZ. PILLOW BAG UPC0 38445 00224 2,  Item #00229 Julian Date: 5014, 5028, 5049, 5065, 5097, 5104, 5105, 5140, 5141, 5155, 5156, 5196, 5224, 5229, 5230, 5266, 5267 & 5286.   FAVORITES MOUNTAIN MIX 7 OZ. STAND UP POUCH UPC 0 38445 12280 3, Item #12080 Best By: 09Jan2016, Best By: 20Jan2016, Best By: 24Jan2016, Best By: 03Feb2016, Best By: 06Feb2016, Best By: 17Feb2016, Best By: 23Feb2016, Best By: 04Mar2016, Best By: 12Mar2016, Best By: 13Mar2016, Best By: 20Mar2016, Best By: 21Mar2016, Best By: 27Mar2016, Best By: 28Mar2016, Best By: 03Apr2016, Best By: 24Apr2016, Best By: 09May2016, Best By: 29May2016, Best By: 30May2016, Best By: 17Jun2016, Best By: 26Jun2016, Best By: 27Jun2016, Best By: 10Jul2016, Best By: 11Jul2016, Best By: 20Jul2016, Best By: 28Jul2016, & Best By: 29Jul2016. FAVORITES (CAN) - MOUNTAIN MIX - 7 OZ. - STAND UP POUCH, UPC 0 38445 12281 0, Item #12081 Best By: 09Jan2016, Best By: 10Jan2016, Best By: 26Mar2016, Best By: 03Apr2016, Best By: 05May2016, & Best By: 30May2016.   FAVORITES (ATLANTIC) - MOUNTAIN MIX - 7 OZ. - STAND UP POUCH, UPC 0 38445 12281 0, Item #12108 Best By: 09Jan2016, Best By: 26Mar2016, & Best By: 05May2016.      BETTER VALU MOUNTAIN MIX 10 OZ. STAND UP POUCH UPC 0 79801 24706 8, Item #24706 Best By: 05Oct15, Best By: 06Oct15, Best By: 17Nov15, Best By: 05Dec15, Best By: 06Dec15, Best By: 02Jan16, Best By: 19Feb16, Best By: 22Feb16, Best By: 04Mar16, Best By: 05Mar16, Best By: 16Mar16, Best By: 06Apr16, Best By: 29Apr16, & Best By: 05Jun16.    CLEAR VALUE MOUNTAIN MIX 10 OZ. STAND UP POUCH, UPC 0 36800 36285 7,  Item #36285 Best By: 28Oct15, Best By: 13Dec15, Best By: 01Feb16, Best By: 16Mar16, Best By: 17Mar16, Best By: 15Apr16, & Best By: 16Apr16.    VALU TIME MOUNTAIN MIX 10 OZ. STAND UP POUCH, UPC 0 11225 09157,  Item #09157 Best By: 14Oct15, Best By: 15Oct15, Best By: 16Oct15, Best By: 26Oct15, Best By: 25Nov15, Best By: 27Nov15, Best By: 02Dec15, Best By: 19Dec15, Best By: 23Dec15, Best By: 08Jan16, Best By: 09Jan16, Best By: 07Feb16, Best By: 08F
The firm was notified that the product contains undeclared Milk.
Sweet & Salty Mix 2.75oz Tube Bag, 5oz Pillow Bag, 6.5oz Pillow Bag, 8oz Stand Up Pouch, 16oz Plastic Jar & 25lb Case. INGREDIENTS: Peanuts (Peanuts, Canola and/or Peanut oil, Salt), Chocolate Buttons***Contains Peanut. Sold under the brand names of: Choice, Speedy & King's.
SPEEDY CHOICE TRAIL MIX SALTY & SWEET 2.75 OZ. TUBE BAG, UPC 0 52894 12062 3  Item # 12077 Best By: 11Feb2016, Best By: 12Feb2016, Best By: 24Feb2016, Best By: 16Mar2016, Best By: 17Mar2016, Best By: 31Mar2016, Best By: 13Apr2016, Best By: 14Apr2016, Best By: 01May2016, Best By: 16May2016, Best By: 18May2016, Best By: 08Jun2016, Best By: 10Jun2016, Best By: 25Jun2016, Best By: 02Jul2016, Best By: 03Jul2016, Best By: 13Jul2016, Best By: 16Jul2016, & Best By: 20Jul2016.   KING'S SWEET & SALTY MIX 5 OZ. - PILLOW BAG , UPC 0 38445 54309 7, Item#54309 Best By: Oct1915, Best By: Oct2015, Best By: Nov0415, Best By: Nov1615, Best By: Jan3016, Best By: Feb2116, Best By: Mar0816, Best By: Mar3016, & Best By: Apr1416.    KING'S SWEET & SALTY MIX 6.5 OZ. - PILLOW BAG, UPC  0 38445 54309 7, Item #51309 Best By: Oct2015, Best By: Oct2715, Best By: Nov1115, Best By: Dec0415, & Best By: Jan3016.    SPEEDY CHOICE TRAIL MIX SALTY & SWEET 8 OZ. STAND UP POUCH, UPC 0 52894 12056 2,  Item #12071 Best By: 08Jan2016, Best By: 09Jan2016, Best By: 06Feb2016, Best By: 13Feb2016, Best By: 11Mar2016, Best By: 24Mar2016, Best By: 06Apr2016, Best By: 20Apr2016, Best By: 01May2016, Best By: 05Jun2016, Best By: 06Jun2016, Best By: 17Jun2016, Best By: 01Jul2016, Best By: 02Jul2016, Best By: 19Jul2016, Best By: 20Jul2016, Best By: 21Jul2016, Best By: 28Jul2016, Best By: 06Aug2016, Best By: 22Aug2016, Best By: 30Aug2016, Best By: 09Sep2016, Best By: 16Sep2016, Best By: 24Sep2016, Best By: 25Sep2016, Best By: 28Sep2016, Best By: 05Oct2016, & Best By: 06Oct2016.    KINGS SWEET & SALTY MIX 16 OZ. PLASTIC JAR, 0 38445 13192 8, Item #13192 Best By: 03-04-16, Best By: 03-27-16, Best By: 07-08-16, & Best By: 09-30-16.    KING'S SWEET & SALTY MIX 25 LB CASE Item# 00389 Julian Date: 5210
Kings fresh & Delicious Cashews & Sweeties Net Wt. 14oz. (397g) INGREDIENTS: Cashews (Cashews, Canola and/or Peanut Oil Salt), CHOCOLATE BUTTONS (Sugar, Partially Hydrogenated Palm Kernel***King Nut Companies Solon, OH 44139 www.kingnut.com 0 38445 49999 8
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm,   Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
NatureBox Sticks 'n Stones; roasted nuts with sesame sticks  4.5 oz (128 g) pouches  - UPC 8 52523 00546 4 and 5 lb. Corporate bags - no UPC;  Ingredients: Sesame Sticks (unbleached flour, malted barley flour, soybean oil, sesame seeds, bulgar wheat, salt, beet powder, turmeric), Cashews, Almonds, Peanut Oil, Salt.    Contains: Wheat and Tree Nuts (Cashews and Almonds).    Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg, soy and fish,    Distributed by:  NatureBox,  San Carlos, CA 94070
8202 x 4.5 oz bags, 95 x 5 lb. corporate bags
Supplier notified firm that the oil used to roast nuts for a trail mix product had also been used to roast peanuts, leading to the possibility of peanut contamination. Peanuts were not listed in the allergen statement.
VA, IL, FL, OH, MN, SC, GA, TX, AL, MO, NC, PA, VT, NY, CT, MA, MS, CA, WV, TN, AL, KY
Herr's Sour Cream & Onion Flavored Potato Chips
UPC No.  7260000061 for all the following Lot Numbers: Jan 2 2016D  Jan 9 2016B  A Jan 9 2016  C Jan 9 2016  Jan 16 2016 A  Jan 16 2016 B  Jan 16 2016 E  D Jan 23 2016  Jan 23 2016 A  Jan 23 2016 C  Jan 30 2016 C
Herr Foods Inc. has initiated a voluntary recall of certain bags of its 1.875 oz. Sour Cream and Onion flavored Potato Chips due to a packaging error that incorrectly states that the product is gluten free.    While the back panel of the package complies with U.S. Food & Drug Administration (FDA) label regulations by listing Wheat in the ingredient statement as well as Contains Wheat in its related allergen statement, the front panel of the package erroneously features the words Gluten Free. Gluten is the protein that naturally occurs in wheat, rye, barley, and crossbreeds of these grains. Most people can eat gluten, but in people with celiac disease, gluten intake gradually damages the intestines, prevents the absorption of vitamins and minerals, and can lead to other health problems. Symptoms can include diarrhea, fatigue, headaches, abdominal pain, brain fog, rashes, nausea, vomiting, and other reactions. Herrs has not received any reported illnesses to date.  Herrs Sour Cream & Onion Potato Chips, 1.875 oz. bags only, were distributed nationwide through retail stores, distributors, and internet sales. These products were sold as individual bags. No other bag sizes of Herrs Sour Cream N Onion Chips are involved with this recall. No other Herrs products are involved with this recall.
7'' Publix Bakery - German Chocolate Layer Cake.  Product is shipped in cases containing 6 individual cakes.
Maplehurst Code: 085421; Publix Code: 117924 - German Choc Banded; Lot Code: 5273D10854110
German Chocolate cake labeled with incorrect ingredient declaration. Label was for Cookies and Creme cake as opposed to German Chocolate cake ingredient and allergen declaration.
Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
MiniArc Pro'' Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx.  Designed to treat female stress urinary incontinence.
Lot number 936405. Serial numbers 936405001 through 936405056
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.
ECG Electrodes:   50007  Stablebase SBW55  50675  Stablebase SBW55-15  58051  Skintact W-60  50547  Stablebase SBT60    Only OUS:  50476 Skintact W-60HP E3 I  58046 Skintact T-60 I Patz K920  58688 Dahlhausen 1900000440  59629 Cardionetics CN-15-W60  58789 Lessa 99.832.02  58872 EF Medica FS 50 LG  50359Ultragel FS50LG
There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.
c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only.  Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
ID Biomedical Corp., a subsidary of GSK Biologicals
FLULAVAL QUADRIVALENT Carton NDC 19515-894-52  Syringe NDC 19515-894-41
2B472AFLHA839A; 42N4LAFLHA822A; 5AZ7HAFLHA820A; 9A3ZMAFLHA841A; ZS95ZAFLHA821A; A2PK7AFLHA821A; AR57JAFLHA832A; DR4GFAFLHA847A; YF5DTAFLHA847A; F45C5AFLHA842A; T3J4SAFLHA819A; XP4J2AFLHA819A; 379MYAFLHA833A;
Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed.