FDA recalls, January 2013: 251 published

110 different companies appear this month.

Risk classification: Class I: 62 · Class II: 157 · Class III: 32

Same month, other agencies:CPSC 32 recallsNHTSA 37 recalls

Recalls this month

DateProduct
January 9, 2013Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham…D-120-2013New England Compounding Center
January 9, 2013Companion External Battery, Part Number: 293001-001 The Companion External Battery is …Z-0620-2013SynCardia Systems Inc.
January 9, 2013Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL via…D-111-2013New England Compounding Center
January 9, 2013La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case.F-0857-2013Gourmet Cuisine, Inc.
January 9, 2013Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg…D-113-2013New England Compounding Center
January 9, 2013Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. h…F-0856-2013Focus Products Group Llc
January 9, 2013Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Cent…D-117-2013New England Compounding Center
January 9, 2013Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps w…Z-0625-2013Hospira Inc.
January 9, 2013Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New …D-122-2013New England Compounding Center
January 9, 2013Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, R…Z-0617-2013St Jude Medical Inc
January 9, 2013Abbott m2000sp Instrument; an automated fluid handling system for performing sample prepa…Z-0634-2013Abbott Molecular
January 9, 2013Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; l…Z-0626-2013Hospira Inc.
January 9, 2013Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8…Z-0621-2013Fisher & Paykel Healthcare, Ltd.
January 9, 2013Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuertte…Z-0627-2013Maquet Inc.
January 9, 2013Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The…Z-0619-2013HemoCue AB
January 9, 2013Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials…D-108-2013New England Compounding Center
January 9, 2013Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by …D-121-2013New England Compounding Center
January 9, 2013Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and…D-124-2013New England Compounding Center
January 9, 2013PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemi…Z-0633-2013Horiba Instruments, Inc dba Horiba Medical
January 9, 2013Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Cente…D-123-2013New England Compounding Center
January 9, 2013Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3…Z-0629-2013Stryker Medical Division of Stryker Corporation
January 9, 2013Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL via…D-110-2013New England Compounding Center
January 9, 2013Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, …D-116-2013New England Compounding Center
January 9, 2013Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Cent…D-115-2013New England Compounding Center
January 9, 2013Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compo…D-118-2013New England Compounding Center
January 9, 2013ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnost…Z-0632-2013Horiba Instruments, Inc dba Horiba Medical
January 9, 2013Fresh Express brand, Fresh Spinach, 9 oz.F-0859-2013Fresh Express Incorporated
January 9, 2013Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Cl…Z-0623-2013B. Braun Medical, Inc.
January 9, 2013Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx On…D-107-2013Abbott Laboratories
January 2, 2013Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Tota…Z-0613-2013Beckman Coulter Inc.
January 2, 2013Zimmer Spine Ardis Inserter, Rx, non-sterileZ-0594-2013Zimmer, Inc.
January 2, 2013Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010…Z-0611-2013Greatbatch Medical
January 2, 2013Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Sm…F-0853-2013Spence & Co., Ltd.
January 2, 2013Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed),…D-105-2013F. Hoffmann-LaRoche Ltd.
January 2, 2013Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm …D-102-2013Lloyd Inc. of Iowa
January 2, 2013Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical Syst…Z-0612-2013Beckman Coulter Inc.
January 2, 2013Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in th…Z-0609-2013sanofi-aventis US, Inc.
January 2, 2013Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVN…Z-0525-2013Praxair Inc.
January 2, 2013COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample…Z-0614-2013Roche Molecular Systems, Inc.
January 2, 2013Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puer…D-104-2013Alara Pharmaceutical Co
January 2, 2013Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-00…Z-0610-2013Stryker Howmedica Osteonics Corp.
January 2, 2013Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm …D-100-2013Lloyd Inc. of Iowa
January 2, 2013Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC …D-103-2013Lloyd Inc. of Iowa
January 2, 2013CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/BoxF-0852-2013Golub Corp
January 2, 2013Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Phil…Z-0479-2013Philips Medical Systems (Cleveland) Inc
January 2, 2013Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed a…F-0854-2013Taylor Farms Retail, Inc.
January 2, 2013Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC …D-101-2013Lloyd Inc. of Iowa
January 2, 2013Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Pl…Z-0616-2013Brookstone Company, Inc.
January 2, 2013GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Cir…Z-0606-2013GE Healthcare, LLC
January 2, 2013Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pum…Z-0615-2013Arjo, Inc. dba ArjoHuntleigh

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