The products were produced under conditions that create a high potential for contamination.
Protamine Zinc for insulin (PZI), 100 units/1mL Vet Insulin
Baytril (enrofloxacin) 0.68 mg/1mL Vet Suspension
Itraconazole  35mg Vet Treats (Tuna Flavor)
Desmopressin Opthalmic Use, sterile solution, 0.01%, eye drops, 5 mL droptainer, Rx only, dispensed by Montana Compounding Pharmacy in Missoula, MT.
Desmopressin Opthalmic Use, 0.01%, eye drop sterile solution is recalled due to lack of sterility assurance.
Distributed to distributors and retailers in AL,  AR,  CA,  FL,  GA,  HI,  IA,  ID,  IL,  IN,  KS,  KY,  LA,  MN,  MO,  MT,  NC,  ND,  NE,  OH,  OK,  OR,  PA,  PR,  TN,  TX,  VA,  WA,  and WI
Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5%, antibacterial for animal use only, packaged in plastic containers.  Net Contents:  16 fl oz (473 ml).  NADA 006-084.  NDC 0010-4708-01.  The responsible firm name on the label is Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO.
43,716 16-oz containers, 5,448 gallon containers
Presence of particulate matter not intrinsic to the manufacturing process.
Sysco Classic All Purpose H and R Flour.
Sysco 25 pound All Purpose Flour: Best By 07/22/2016; Always Save 5 pound All Purpose Flour: Best By 07/23/2016; Best Choice 5 pound All Purpose Flour: Best By 07/23/2016; Hy Top 5 pound All Purpose Flour: Best By  07/24/2016
591 bales; eight 5 pound bags in 1 bale, 50 pound bags are not baled, two 25 pound bags in 1 bale.
Shawnee Milling Company Hotel And Restaurant Self Rising Climax Four Net 50 Lbs.; Always Save Self-Rising Flour Enriched Bleached Net Wt 5 LB (2.26kg) in waxed paper bag; Best Choice Flour Self-Rising Enriched Bleached Net Wt 5 LB (2.26 kg) in wax paper bag; HyTop Enriched Flour Bleached Self-Rising Net Wt 5 LB (2.27 kg) in waxed paper bag; Parade Enriched Flour Bleached Self-Rising Net Wt 5 LB (2.27kg) in waxed paper bag; Shawnee Best Self Rising Flour Bleached Enriched Pre-Sifted net Wt. 5 LB. (2.268 kg) in waxed paper bag; Shur fine self-rising bleached & enriched flour Net Wt 5 LB (2.27kg) in waxed paper bag.
Climax Flour: Best By 07/24/2016; Always Save: Best By 07/22/2016; Best Choice: Best By 07/22/2016; HyTop: Best By 07/22/2016; Parade: Best By 07/21/2016; Shawnee Best: Best By 07/21/2016, Best By 07/22/2016; Shurfine: Best By 07/21/2016, 07/22/2016
1601 bales; eight 5 pound bags are in 1 bale, 50 pound bags are not baled, two 25 pound bags in 1 bale.
it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Glutinous Rice, Net WT. 1000 g, packaged in plastic bottles,  UPC 6958020881168, Made in China
Win Luck is recalling Grove Grow Notes Glutinous Rice because it contains undeclared alcohol.
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg,  10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO  64111; UPC 0 7003861209 4
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY  14086
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item  876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI  02895
Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box,  Distributed by: Drug Mart-Food Fair, Medina, OH  44256, UPC 0 93351 12101 2.
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN  55344 USA
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN  38118, UPC 0 8457912198 4.
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA  19087
Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA  94104, NDC 62011-0073-1, UPC 0 5256913369 9
HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH  43017, NDC 37205-745-65, UPC 0 9629512322 7
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box,  Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b)  30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA  94566
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL  60007.
Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box,  Distributed by Target Corp, Minneapolis, MN  55403; NDC 11673-527-31, UPC 3 5166052731 5
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b)  30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA  94104
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL  60015
Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI  49544. NDC 41250-527-31, UPC 7 6023662291 8
Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data
Natus Neurology has discovered that when using he NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.
Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Manufacturing lot 1214-F-403 and 1214-V-424
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor for whom there was no documentation of  checking the arm, mouth, or general appearance on the day of donation, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
U.S. distribution to the following: SC, FL, WI, NE, OH, CA, GA, LA, MI, CO, AL, IN, AZ, TX, MN. No foreign distribution.
Caravelle ABC Cookies Banh Chu  NET WT: 7oz (200gr)  Product of Vietnam
Anhing Corporation is recalling Caravelle ABC Cookies because recent analysis revealed each cookie contained a lead level of 0.13 ppm and 13 ppm per labeled serving size.  In addition the label did not declare flour as wheat flour, and stated the product contained vegetable oil when it was refined coconut oil.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was shipped to the following states: AL, AR, CA, CO, CT, FL,HI, IL, KS, KY, MA, MD, ME, MI, MN, MO, MS, NJ, NY, OK, OR, PA, SC, TN, TX, VA, VT, WA & WI.
French Burnt Peanuts, NET WEIGHT 8 OZ (227g) Old Time Candy.com Distributed by Old Time Candy Company  LaGrange, OH 44050 www.oldtimecandy.com Ingredients: Dextrose, Citric Acid, Calcium Stearate, Artificial Flavors, Artificial Colors***. May Contain Milk And Soy.
The firm has the incorrect ingredient statement on the package.  The ingredient statement fails to list the allergen ''Peanuts'', Sugar, artificial colors (Red 3 & Blue 2), and Salt.
Alere Cholestech LDX  Multianalyte Controls, PN 88769 and 88773.   Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Zimmer Natural Nail CM Long.  Intramedullary Fixation Rod.     The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
In about 5% of tested samples, the outer tray was found to be compromised. Risks:  A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant.  If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
US (nationwide) distribution and one Internationally to Australia.
Inserter for Titanium Elastic Nails (TEN), orthopedic device
potential for mechanical failures such as breakage.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD.    No foreign consignees.
-Pipeline Embolization Device -Pipeline Flex Embolization Device    The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system.  The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires.    The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
US Distribution to the states of :  CA, MO and WI., and Internationally to Korea.
MRIdian ViewRay Radiation Therapy System, ViewRay    Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia
Monode, Shortwave Accessory, Model number 0220000, used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units.  For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
Model #: 02200002   All units received from the manufacture prior to the week of July 12, 2015
Overheating and burning of the wire insulation inside the applicator.
Domestic: AR, AZ, CA, CT, DC, FL, GA ,IA,  IL,  KS, MA, ME, MI, MN, NC, NH, NJ, NV, NY,OH,PA,TX, WA, WI   Foreign: None  VA/DOD: None
GoGo SQueeZ Applesauce, Apple Apple, individually wrapped in foil pouch in cardboard carton; sizes include: 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
All lots with Best by Dates: 06/29/16 - 07/27/16
Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold.
GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Carrot Mixed Berry, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Mango, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Organic Apple, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Organic Apple Peach, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential al presence of mold.
GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential  presence of mold.
GoGo SQueeZ Applesauce, Berry Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Apple Strawberry, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
GoGo SQueeZ Applesauce, Variety Packs, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054, By: Ferring Gmbh, Kiel Germany, NDC 55566-8505-6
Subpotent Drug: Stability samples were confirmed to be out of specification for potency at the 12 month time point.
U.S. distribution to the following; AZ. No foreign distribution.
Candy El Pecas  Mango Chile  Net wt. 1.5oz.  UPC: 6 66030 00009 2
Product packaged betwen 15 march to  June 30 2015
Perez Casas Enterprises, Inc. is recalling Candy El Pecas Mango Chile and Watermelon Flavor due to undeclared Yellow #5 and Red #40.
Candy El Pecas  Paleta de Sandia  watermelon lollipops  NET WT. 2.5oz
Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P-P  (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P-P  (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX  77043, UPC: 1 88436 00017 4.
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device.  Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
4FR Single Lumen Pressure Injectable PICC; catheter,intravascular,therapeutic,long-term greater than 30 days
labeling inaccuracy in the Instructions for Use (IFU) and Patient Card.
WellPatch Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566
Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Labeling: Incorrect Instructions; The word not is missing from the following sentences ''do bandage tightly or cover with any type of wrap except clothing and ''do use with a heating pad or with other heat sources in the Drug Facts panel ''Warning'' section
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Lot no. 37603 Expiration date: September 2016
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Product was shipped to the following states: IN, KY, MA, MD, MI, NY, OH, PA & TX.
TASTEE Plain Caramel Apple, www.tasteeapple.com NET WT. 3 OZ 85g 0 35266 00027 3 ''THIS PRODUCT CONTAINS THE FOLLOWING ALLERGENS: MILK AND SOYBEAN***'' TASTEE APPLE INC. NEWCOMERSTOWN, OH 43832
The firm was notified by a customer that their Plain Caramel Apples contains peanuts and the label does not list peanuts in the ingredient statement..
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL  33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
US Distribution to states of:OH, IL, PA, WV, FL, AZ, CA, AL, ND, KY, MN, NJ, MI, GA, IN, TN, VA, NC, and LA.
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile   The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, '' Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. '' Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
Product Description Part Numbers Lot Numbers 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile 02.117.410S                   8009075  2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile 02.117.610S    8007085
The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA  19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA  19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA  19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA  19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA  19124 USA.