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, 2013Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-6003…Z-1958-2013SpineFrontier, Inc.
August 21, 2013buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 bliste…D-892-2013American Health Packaging
August 21, 2013Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain th…Z-1957-2013SpineFrontier, Inc.
August 21, 2013CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRAC…Z-1950-2013Veridex, LLC
August 21, 2013StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structu…Z-1956-2013Medtronic Navigation, Inc.
August 21, 2013Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are ki…Z-1901-2013Nova Biomedical Corporation
August 21, 2013HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-869-2013Pallimed Solutions
August 21, 2013Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product…Z-1974-2013Terumo Cardiovascular Systems Corporation
August 21, 2013Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz.…F-1811-2013Crave Brothers Farmstead Cheese, LLC
August 21, 2013Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lum…Z-1965-2013Arrow International Inc
August 21, 2013Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 c…D-883-2013West-Ward Pharmaceutical Corp.
August 21, 2013Bulk tablet label: Keytabs W.O. Glandulars (pink)F-1802-2013Ancient Formulas Inc
August 21, 2013epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples …Z-1971-2013Epocal
August 21, 2013Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Ter…Z-1969-2013Terumo Cardiovascular Systems Corporation
August 21, 2013KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product o…F-1803-2013Ancient Formulas Inc
August 21, 2013Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 …Z-1906-2013Nova Biomedical Corporation
August 21, 20133M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 917…D-889-2013Total Resources Intl
August 21, 2013Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-879-2013Pallimed Solutions
August 21, 2013Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Teru…Z-1968-2013Terumo Cardiovascular Systems Corporation
August 21, 2013Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-871-2013Pallimed Solutions
August 21, 2013C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencie…Z-1938-2013Atrium Medical Corporation
August 21, 2013GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualifi…Z-1944-2013GE Healthcare, LLC
August 21, 2013Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethyle…Z-1966-2013Medtronic Inc. Cardiac Rhythm Disease Management
August 21, 2013(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET …D-891-2013Total Resources Intl
August 21, 2013Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova M…Z-1904-2013Nova Biomedical Corporation
August 21, 2013Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usa…Z-1903-2013Nova Biomedical Corporation
August 21, 2013C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.Z-1937-2013Atrium Medical Corporation
August 21, 2013Spartan Fresh Dark Chocolate Covered Dried Cherries 8ozF-1797-2013Shoreline Fruit Inc
August 21, 2013Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries 25lbsF1798-2013Shoreline Fruit Inc
August 21, 2013Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-865-2013Pallimed Solutions
August 21, 2013individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as " Jennies DUTC…F-1796-2013Red Mill Farms
August 21, 2013GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are in…Z-1942-2013GE Healthcare, LLC
August 21, 2013Cherry Bay Orchards Dark Chocolate Covered Dried Balaton Cherries 4lb, 8oz, and 16oz con…F-1799-2013Shoreline Fruit Inc
August 21, 2013Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MAD-860-2013Pallimed Solutions
August 21, 2013REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere …Z-1953-2013Zimmer, Inc.
August 21, 2013Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bag…F-1805-2013Ferrara Candy Company
August 14, 2013Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2…D-844-2013Novartis Consumer Health
August 14, 2013Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Pro…Z-1924-2013Siemens Healthcare Diagnostics, Inc.
August 14, 2013MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the M…Z-1874-2013Iradimed Corporation
August 14, 2013Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 46…Z-1887-2013Cordis Corporation
August 14, 2013Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of …Z-1876-2013Medtronic Inc. Cardiac Rhythm Disease Management
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1914-2013Biomerieux Inc
August 14, 2013bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automate…Z-1920-2013Biomerieux Inc
August 14, 2013Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufac…D-852-2013Apotex Inc
August 14, 2013Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion withi…Z-1933-2013SpineFrontier, Inc.
August 14, 2013Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265…D-853-2013West-Ward Pharmaceutical Corp.
August 14, 2013Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 T…F-1790-2013Giant Eagle
August 14, 2013Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantit…Z-1883-2013Siemens Healthcare Diagnostics, Inc
August 14, 2013Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The…Z-1879-2013Stryker Instruments Div. of Stryker Corporation
August 14, 2013CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Ster…Z-1888-2013ASO, LLC

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