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, 2013VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only…D-839-2013West-Ward Pharmaceutical Corp.
August 14, 2013Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx…D-849-2013Teva Pharmaceuticals USA, Inc.
August 14, 2013Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with …Z-1927-2013SpineFrontier, Inc.
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1912-2013Biomerieux Inc
August 14, 2013TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile l…Z-1895-2013ASO, LLC
August 14, 2013Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated c…Z-1873-2013Beckman Coulter Inc.
August 14, 2013Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx…D-848-2013Teva Pharmaceuticals USA, Inc.
August 14, 2013Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reu…D-837-2013Reumofan Plus USA
August 14, 2013Raw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistac…F-1795-2013Superior Nut Co. Inc.
August 14, 2013Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged …D-854-2013Sandoz Incorporated
August 14, 2013No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by…D-845-2013Novartis Consumer Health
August 14, 2013Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly…Z-1835-2013CareFusion 303, Inc.
August 14, 2013IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T…Z-1886-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: …Z-1878-2013Stryker Instruments Div. of Stryker Corporation
August 14, 2013List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin an…Z-1852-2013Hospira Inc.
August 14, 2013BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 U…Z-1923-2013Becton Dickinson & Company
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1910-2013Biomerieux Inc
August 14, 2013IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2K…Z-1885-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-…Z-1858-2013Hospira Inc.
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1909-2013Biomerieux Inc
August 14, 2013Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and …D-846-2013Novartis Consumer Health
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1916-2013Biomerieux Inc
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1911-2013Biomerieux Inc
August 14, 2013The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. Th…F-1786-2013Aqua Star (USA) Corp.
August 14, 2013Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. …Z-1890-2013ASO, LLC
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1917-2013Biomerieux Inc
August 14, 2013Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure h…Z-1882-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are sili…Z-1932-2013SpineFrontier, Inc.
August 14, 2013List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Mic…Z-1854-2013Hospira Inc.
August 14, 2013Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg)…D-843-2013Novartis Consumer Health
August 14, 2013HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex…Z-1891-2013ASO, LLC
August 14, 2013List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 …Z-1856-2013Hospira Inc.
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1921-2013Biomerieux Inc
August 14, 2013TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tabl…D-850-2013GlaxoSmithKline, LLC.
August 7, 2013Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation …Z-1864-2013Acclarent, Inc.
August 7, 2013Exactech Articulated Driver A nonpowered hand-held device intended for medical purpos…Z-1832-2013Exactech, Inc.
August 7, 2013Fisher's Homestyle Salads LLC***Cheddar Potato Soup w/Bacon*** packaged in 5 lb and 10 lb…F-1756-2013Fisher's Homestyle Salads
August 7, 2013Penny's Roasted Red Pepper Hummus 12 oz has UPC 7 49404 51848 2; Harbor Greens Roasted R…F-1773-2013Hagee Foods Inc.
August 7, 2013PENNY'S CREAMY HUMMUS 12 oz has UPC 7 49404 90971 6; PENNY'S SALSA Creamy Original Hummu…F-1771-2013Hagee Foods Inc.
August 7, 2013Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distrib…Z-1825-2013Steritec Products Mfc. Co., Inc.
August 7, 2013Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP …D-826-2013Physicians Total Care, Inc.
August 7, 2013Penny's Hummus De Gallo 12 oz has UPC 7 49404 32368 0; Harbor Greens Hummus De Gallo 8 …F-1772-2013Hagee Foods Inc.
August 7, 2013Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in det…Z-1868-2013Mesa Laboratories, Inc., Bozeman Manufacturing Facility
August 7, 2013El Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged …F-1760-2013El Campestre
August 7, 2013Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining t…Z-1867-2013Mesa Laboratories, Inc., Bozeman Manufacturing Facility
August 7, 2013Fisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic…F-1758-2013Fisher's Homestyle Salads
August 7, 2013El Campestre Brand Ceviche Mixto De Basa. Packaged in 2/5lbs white plastic buckets wit…F-1763-2013El Campestre
August 7, 2013El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with l…F-1764-2013El Campestre
August 7, 2013Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kid…F-1745-2013Ozark Bottling, LLC
August 7, 2013El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid an…F-1762-2013El Campestre

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