Recalling Firm
Stryker Instruments Div. of Stryker Corporation
Inova Health Care Services, Inova Blood Donor Services
Oregon Compounding Centers, Inc. dba Creative Compounds

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.
The recalled items are distributed nationwide and sold to retail stores, some of them in bulk for the sales of smaller quantities to their customers.
Nationwide Distribution including Puerto Rico, and the country of Canada.
International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.
Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.
Product was distributed to: CA, FL, IA, IN, MI, MO, MS, OK, PA, SD, TN, TX, WI, and Puerto Rico.
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.
Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Unit.Arab Emir., Vatican, Yemen, AR, AU, BD, BR, CA , CH, CL, CN, CO, DO, EC, EG, GT, HK, ID, IE, IL, IN, JP, KR, LY, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VN, ZA
Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.
US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)
Nationwide and to India. No govt/military/VA consignees.
Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.
Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
Nationwide throughout the US and in Canada
US Distribution including the states of CA, GA, NJ, NY, OR and PA.
Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
National: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, TN, TX, U.S.VIRGIN ISLANDS, VA, WA, WI INTNL: CANADA
AL, FL, GA, LA, MA, MD, MI, NC, NY, PA, SC, VA, and WI.

Product Description
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector'' that is the subject of this correction/removal activity
Eukanuba Dog Food Base Large Breed Mature Adult, 15 lb. (UPC: 19014270156), and 30 lb. (UPC: 19014270309) bags
Eukanuba Dog Food Base Maintenance Mature Adult, 30 lb bag, UPC: 19014149308
Eukanuba Dog Food Base Small Breed Adult, 4 lb (UPC: 19014039722) and 16 lb (UPC: 19014010516) bags
Eukanuba Dog Food Breed Specific Chihuahua Adult, 4 lb bags, UPC: 19014607037
Eukanuba Dog Food Breed Specific Labrador Retriever Adult, 36 lb bags, UPC: 19014019564
Eukanuba Dog Food Premium Performance 30/20 Adult, 33 lb bags, UPC: 19014609475
Eukanuba Dog Food Professional Feeding Bag Small Breed Puppy, 44 lb bags, UPC: 19014113194
Eukanuba Dog Food Weight Control Large Breed Adult, 30 lb bags, UPC: 19014269303
Iams Dog Food Healthy Naturals Weight Control Adult, 13.3 lb bags, UPC: 19014612024
Iams Dog Food Premium Protection Chicken Adult, 12.1 lb bags, UPC: 19014611362
Iams Dog Food ProActive Health Large Breed Senior Plus, 13.3 lb (UPC: 19014612000) and 26.2 lb bags (UPC: 19014700615)
Iams Dog Food ProActive Health Large Chunks Adult, 15 lb bags, UPC: 19014610815
Iams Dog Food ProActive Health Small Breed Adult, 3.1 lb (UPC: 19014700110), 13.3 lb (UPC: 19014610990) and 5 lb bags (UPC: 19014612055)
Iams Dog Food ProActive Health Small Breed Puppy, 5 lb bags UPC: 19014700943
Iams Cat Food Healthy Naturals Chicken Adult, 5 lb (UPC: 19014612697) and 16 lb bags (UPC: 19014611881)
Iams Cat Food Healthy Naturals Weight Control Adult, 5 lb bags, UPC: 19014612703
Iams Cat Food ProActive Health Chicken Kitten, 3.2 lb (UPC: 19014612628), 5.7 lb (UPC: 19014612505), 17.4 lb bags (UPC: 19014611867)
Iams Cat Food ProActive Health Digestive Care Adult, 3 lb (UPC: 19014700202), 5 lb (UPC: 19014612451) and 16 lb bags (UPC: 19014611904)
Iams Cat Food ProActive Health Hairball Mature Adult, 5 lb bags, UPC: 19014612604
Iams Cat Food ProActive Health Weight Control Adult, 5 lb (UPC: 19014612680), 9.8 lb (UPC: 19014612123) and 16 lb bags (UPC: 19014612178)
Iams Cat Food Professional Feeding Bag Chicken Adult, 33 lb bags, UPC: 19014105458
Eukanuba Dog Food Base Maintenance Puppy, 5 lb. (UPC 19014039852), 16.5 lb. (UPC 19014042234), and 33 lb. (UPC 19014609468) bags
Eukanuba Dog Food Base Small Breed Puppy, 4 lb. (UPC 19014039678), 16 lb. (UPC 19014010509), and 40 lb. (UPC 19014011070) bags
Eukanuba Dog Food Breed Specific Boxer Adult, 36 lb. bags (UPC 19014019588)
Iams Dog Food ProActive Health Large Breed Mature Adult, 30 lb. bags (UPC 19014611331)
KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC. 13 MEADOW STREET, BROOKLYN, NY 11206, USA TEL: 718-381-0306 FAX: 718-381-0089 --- The product is packed in a clear, hard plastic container.
GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink label and contains 14 - 2 lb bags per case. Manufactured by S&A Grandma's Food Inc. 196-44 Fasken Drive Toronto, ON M9W 5M8 (416) 679-8444, www.grandmafoods.com. Product of Canada.
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Carob Supergreens Chunks of Energy (10# UPC 7-69270-10009-7); also, Carob Supergreens Chunks of Energy and Rave BItes Brand Carob Supergreens (7 oz UPC 7-69270-70008-8).
Date Flax with Turmeric Chunks of Energy (10# UPC 7-69270-20004-5); also Date Flax Turmeric Chunks of Energy and Rave Bites Date Flax with Turmeric (7 oz UPC 7-69270-70006-4).
Bulk organic Carob powder (10# UPC 7-69270-80001-6)
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Invitrogen by Life Technologies, DPB1 SSP UniTray, DPB1 SSP UniTray with Taq, AllSet Gold DPB1 High Res SSP.
Red Blood Cells (Apheresis) Leukocytes Reduced
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Prescription eyeglass safety lenses. Vision correction
Clindamycin hydrochloride oral liquid, 25 mg per mL, in 20-ml. plastic bottles, RX, ANDA #200-291, packaged under the following labels: (1) Virbac Animal Health Clinsol Liquid, NDC 051311-500-25, Mfd. by Virbac AH, Inc., Fort Worth, TX; and (2) VEDCO ClindaCure, NDC 050989-495-09, Mfd. for VEDCO, Inc., St. Joseph, MO.
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife'' Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife'' Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032
Mama Tere Arepa de Blanca de Maiz White Corn Patty 14.1 oz/400g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011676
Mama Tere Arepa de Moto Hominy Patty 14.1 oz / 400 g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011652
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
Phenylephrine 1% injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
''Tri-mix'' 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337
Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.
Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # 04970540898
Asian 7 Rice Cracker Mix in Bulk 22 lb. cases; Wood Stock Farms Lot # YOUI03 sold to Publix Bakery Plant in Lakeland, FL, and to The Nutman Company - USA Inc., in Hubertus, WI.
ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed by: Giorgio Foods, Inc., PO Box 96, Temple, PA 19560 Manufactured 3/27/2014 Best by 3/27/2015 Product 8512 Lot 14086
Whole Foods Vegan Gingersnap Cookies, 6pk (10-oz), packaged in flexible plastic with twist tie
Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ
Bailey Farms, Fresh Serrano Chile Peppers, Oxford, NC 27565.

Code Info
Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0
Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.
Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.
Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0
Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.
Lot Code: 31874177, Best by Date: 6Nov14.
Lot Code: 31954177, Best by Date: 14Nov14.
Lot Code: 31904177, Best by Date: 9Nov14.
Lot Code: 31884177, Best by Date: 7Nov14.
Lot Code: 31894177, Best by Date: 8Nov14, Lot Code: 31924177, Best by Date: 11Nov14.
Lot Code: 31944177, Best by Date: 13Nov14 (2.9 lb.); Lot Code: 31904177, Best by date: 9Nov14 and Lot Code: 31914177, Best by Date: 10Nov14 (5 lb); Lot Code: 31884177, Best by Date: 7Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31924177, Best by Date: 11Nov14; Lot Code: 31934177, Best by Date: 12Nov14 and Lot Code: 31944177, Best by Date: 13Nov14 (13.3 lb) and Lot Code: 31884177, Best by Date: 7Nov14; Lot Code: 31894177, Best by Date: 8Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31914177, Best by Date: 10Nov14; and Lot Code: 31934177, Best by Date: 12Nov14 (25.7 lb).
Lot Code: 31894177, Best by Date: 8Nov14
Lot Code: 31894177, Best by Date: 8Nov14.
Lot Code: 31934177, Best by Date: 12Nov14 (both sizes)
Lot Code: 31944177, Best by Date: 13Nov14
Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31894177, Best by Date: 8Nov14 (3.1 lb), Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31894177, Best by Date: 8Nov14 & Lot Code: 31924177, Best by Date: 11Nov14: (5 lb), and Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31894177, Best by Date: 8Nov14 and Lot Code: 31924177, Best bt Date: 11Nov14 (13.3 lb).
Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (5 lb) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (16 lb).
Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31924177, Best by Date: 11Nov14; Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (3.2 lb); Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (5.7 lb); Lot Code: 31944177, Best by Date: 13Nov14 (6.3 lb); Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (10.8 lb) and Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (17.4 lb).
Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3.2 lb) & Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best By Date: 14Nov14 (5.7 lb) and Lot Code: 31904177, Best by Date: 9Nov14 (17.4 lb).
Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3 lb); Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (5 lb) and Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best by Date: 14Nov14 (16 lb).
Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3.1 lbs); Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31934177, Best by Date: 12Nov14, Lot Code: 31954177, Best by Date: 14Nov14 (5 lbs); Lot Code: 31894177, Best by Date: 8Nov14, and 31914177, Best by Date: 10Nov14 (9.8 lbs.); Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (16 lb).
Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14, Lot Code: 31944177, Best by Date: 13Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (2.9 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (5 lbs); Lot Code: 31924177, Best by Date: 11Nov14 (5.5 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (9.8 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 and Lot Code: 31944177, Best by Date: 13Nov14 (16 lbs).
Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31934177, Best by Date: 12Nov14 (5 lbs); Lot Code: 31874177, Best by Date: 6Nov14 (9.8 lbs) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31934177, Best by Date: 12Nov14 (16 lbs).
Lot Code: 31914177, Best by Date: 10Nov14 and Lot Code: 31944177, Best by Date: 13Nov14.
Lot Code: 31884177, Best by Date: 7Nov14
Lot Code: 31874177, Best by Date: 6Nov14 (4 lb); Lot Code: 31944177, Best by Date 13Nov14 (16 lb) and Lot Code: 31874177, Best by Date 6Nov14 & Lot Code: 31944177, Best by Date 13Nov14 (40 lb).
Lot Code: 31944177, Best by Date: 13Nov14 and Lot Code: 31954177, Best by Date 14Nov14 .
Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014
Product code: 2B8011 Lot Number: UR13D15112
Product code 2B8013 Lot Number: UR13K14095
No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28
Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015
Part Number 7126-120-000; All lot numbers from 13027 to 14093
Part Number 7222-120-000; All lot numbers from 13072 to 14121
Lot Number and Expiration Date: 1) Lot 05082014@23, Expires 11/4/2014
Lot Number and Expiration Date: 1) Lot 08012014@34, Expires 10/30/2014
Lot Number and Expiration Date: 1) Lot 07302014@33, Expires 10/28/2014
Product code: 042316, Lot number: BMXJM031
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
GINTBC lot 13118; GINOV lot 13613; both with expiry dates of 9/24/16.

Product Quantity
Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units
Catalog: 16579 ; Catalog 6375: 3256 units
49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles
340 capsules (17 bottles containing 20 capsules each)

Reason for Recall
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.
Product has the potential to be contaminated with Salmonella.
The product was found to contain undeclared sulfites (268.8 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Buffalo SAV, Inc. has recalled GRANDMA'S perogies POTATO & BACON PEROGIES due to the presence of Undeclared Soy.
Source Plasma units, collected from ineligible donors, were distributed.
Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.
Product may be contaminated with Salmonella.
Particulate matter found inside the fluid path.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
HLA typing assay, associated with false negative results, were distributed.
Blood products, collected from a donor who was at risk for leishmaniasis, were distributed.
TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
Prescription eyeglass safety lenses did not meet specifications.
Failing stability specifications at the 18 month time point.
Failed Dissolution Specification; 12 month stability timepoint
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Human Cornea, recovered from a donor whose donor eligibility determination failed to assure the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Merit Medical Systems, Inc. is voluntarily recalling the Merit Maestro Microcatheter due to a discrepancy between the labeling and the actual configuration of the device in the packaging. These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
An ingredient, Tid-bit Potato, tested positive for Listeria monocytogenes. The Tid-Bit Potatoes is an ingredient in Fiesta Breakfast Scramble
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
The product is being recalled due to the potential presence of Salmonella.
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection
The single leg of the PAY connector has been observed to become detached.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
High Quality Organics was notified by customer that representative sample of Organic Ginger (Tea Bag Cut) tested positive for Salmonella
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
Calzone recalled due to potential metal contamination. Product manufactured for the National School Lunch Program.
Product mislabeled- undeclared walnut, almond, milk, soy and egg.
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6.
Product was found to be contaminated with Salmonella
Plateletphereis products lacking assurance of proper leukoreduction were distributed.