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 21, 2013RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g)…F-1807-2013Gold Star Smoked Fish Corp.
August 21, 2013CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELL…Z-1949-2013Veridex, LLC
August 21, 2013ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN …Z-1970-2013Siemens Healthcare Diagnostics, Inc
August 21, 2013Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MAD-878-2013Pallimed Solutions
August 21, 2013REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere …Z-1954-2013Zimmer, Inc.
August 21, 2013BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-861-2013Pallimed Solutions
August 21, 2013Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The …Z-1973-2013Terumo Cardiovascular Systems Corporation
August 21, 2013Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS1751…Z-1963-2013Edwards Lifesciences, LLC
August 21, 2013"***Gasco Golden Egg Yellow Shade Liquid***" 32 oz plastic bottles & 15 gallon drumsF-1808-2013Gasco Industrial
August 21, 2013C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.Z-1936-2013Atrium Medical Corporation
August 21, 2013Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919…F-1804-2013Walong Marketing, Inc.
August 21, 2013Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-866-2013Pallimed Solutions
August 21, 2013Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-858-2013Pallimed Solutions
August 21, 2013Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions…D-876-2013Pallimed Solutions
August 21, 2013Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per bliste…D-882-2013Boehringer Ingelheim Roxane Inc
August 21, 2013ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems…Z-1951-2013Beckman Coulter Inc.
August 21, 2013Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-859-2013Pallimed Solutions
August 21, 2013Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 l…F-1809-2013Crave Brothers Farmstead Cheese, LLC
August 21, 2013Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid…D-884-2013Dr. Reddy's Laboratories, Inc.
August 21, 20133.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to …Z-1941-2013OrthoPediatrics Corp
August 21, 2013Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: Th…Z-1898-2013Nova Biomedical Corporation
August 21, 2013Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanen…Z-1877-2013Carestream Health Inc.
August 21, 2013MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-872-2013Pallimed Solutions
August 21, 2013Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product U…Z-1900-2013Nova Biomedical Corporation
August 21, 2013Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-864-2013Pallimed Solutions
August 21, 2013FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; …F-1806-2013Zip International Group LLC.
August 21, 2013Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches…Z-1955-2013Fisher Scientific Co
August 21, 2013DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-867-2013Pallimed Solutions
August 21, 2013REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 …D-893-2013Showline Automotive Products, Inc. dba US Soaps Mfg. Company
August 21, 2013Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MAD-880-2013Pallimed Solutions
August 21, 2013100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusio…Z-1977-2013Terumo Cardiovascular Systems Corporation
August 21, 2013C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficienc…Z-1939-2013Atrium Medical Corporation
August 21, 2013Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)Z-1961-2013Biomet 3i, LLC
August 21, 2013Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-863-2013Pallimed Solutions
August 21, 2013Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-868-2013Pallimed Solutions
August 21, 2013Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: …Z-1897-2013Nova Biomedical Corporation
August 21, 2013Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St…F-1800-2013Tortilleria Lupita, Inc.
August 21, 2013Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, W…D-877-2013Pallimed Solutions
August 21, 2013Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-857-2013Pallimed Solutions
August 21, 2013Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each packa…Z-1962-2013Remel Inc
August 21, 2013Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radio…Z-1975-2013Siemens Medical Solutions USA, Inc
August 21, 2013Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion …D-887-2013Hospira Inc.
August 21, 2013Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product us…Z-1902-2013Nova Biomedical Corporation
August 21, 2013Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: …Z-1899-2013Nova Biomedical Corporation
August 21, 2013Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MAD-875-2013Pallimed Solutions
August 21, 2013IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat,…F-1801-2013C H S Inc
August 21, 2013Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MAD-870-2013Pallimed Solutions
August 21, 2013Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-881-2013Pallimed Solutions
August 21, 2013Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, T…D-890-2013Total Resources Intl
August 21, 2013Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organicall…D-885-2013Bracco Diagnostics Inc

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