FDA recalls, August 2013: 414 published

149 different companies appear this month.

Risk classification: Class I: 71 · Class II: 306 · Class III: 37

Same month, other agencies:CPSC 24 recallsNHTSA 75 recalls

Recalls this month

DateProduct
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1918-2013Biomerieux Inc
August 14, 2013Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).D-833-2013Chang Kwung Products
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1919-2013Biomerieux Inc
August 14, 2013Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh…Z-0477-2013Arjo, Inc. dba ArjoHuntleigh
August 14, 2013Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packag…F-1793-2013Olde Thompson, Inc.
August 14, 2013Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Ste…D-851-2013Hospira, Inc.
August 14, 2013Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi…D-841-2013Sanofi US
August 14, 2013Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: C…D-838-2013Zydus Pharmaceuticals USA Inc
August 14, 2013Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx…D-847-2013Teva Pharmaceuticals USA, Inc.
August 14, 2013MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd…D-840-2013AstraZeneca Pharmaceuticals LP
August 14, 2013Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 Fren…Z-1922-2013Nestle HealthCare Nutrition
August 14, 2013BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottl…D-855-2013Actavis Inc
August 14, 2013Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in…Z-1889-2013ASO, LLC
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1908-2013Biomerieux Inc
August 14, 2013Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kina…Z-1925-2013Siemens Healthcare Diagnostics, Inc.
August 14, 2013R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE…Z-1928-2013Smith & Nephew Inc
August 14, 2013R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE…Z-1929-2013Smith & Nephew Inc
August 14, 2013Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 …Z-1896-2013ASO, LLC
August 14, 2013Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Ste…Z-1894-2013ASO, LLC
August 14, 2013Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The …Z-1880-2013Stryker Instruments Div. of Stryker Corporation
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1913-2013Biomerieux Inc
August 14, 2013Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8…D-834-2013Chang Kwung Products
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1907-2013Biomerieux Inc
August 14, 2013Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva …D-842-2013Teva Pharmaceuticals USA, Inc.
August 14, 2013VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only …Z-0833-2013Ventana Medical Systems Inc
August 14, 2013Sunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz.F-1787-2013Golden Beach Inc
August 14, 2013Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile la…Z-1892-2013ASO, LLC
August 14, 2013ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500…Z-1881-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instru…Z-1926-2013SpineFrontier, Inc.
August 14, 2013TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21…Z-1930-2013Radiometer America Inc
August 14, 2013Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitativ…Z-1884-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 carto…D-856-2013American Health Packaging
August 14, 2013List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP…Z-1855-2013Hospira Inc.
August 14, 2013Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Produ…F-1788-2013Olam Tomato Processors, Inc.
August 14, 2013Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Swed…Z-0476-2013Arjo, Inc. dba ArjoHuntleigh
August 14, 2013Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose V…D-832-2013Sandoz Incorporated
August 14, 2013List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Ad…Z-1853-2013Hospira Inc.
August 14, 2013Mobiletta Mira Mobile X-ray SystemZ-1875-2013Siemens Medical Solutions USA, Inc
August 14, 20130.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., …D-836-2013Hospira Inc.
August 14, 2013Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile l…Z-1893-2013ASO, LLC
August 14, 2013Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Pro…F-1789-2013Olam Tomato Processors, Inc.
August 14, 2013Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Dr…Z-1871-2013SpineFrontier, Inc.
August 14, 2013List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Adm…Z-1851-2013Hospira Inc.
August 14, 2013Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial…D-835-2013Apotex Corp.
August 14, 2013MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Pro…Z-1931-2013MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
August 14, 2013List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood P…Z-1850-2013Hospira Inc.
August 14, 2013VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only …Z-0834-2013Ventana Medical Systems Inc
August 14, 2013List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80…Z-1857-2013Hospira Inc.
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1915-2013Biomerieux Inc
August 14, 2013Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot P…Z-1872-2013Precision Dynamics Corporation

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