FDA recalls, August 2014: 374 published

129 different companies appear this month.

Risk classification: Class I: 36 · Class II: 316 · Class III: 22

Same month, other agencies:FSIS 6 recallsNHTSA 57 recalls

Recalls this month

DateProduct
August 27, 2014FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized …F-2346-2014Fish Family Farm
August 27, 2014DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distrac…Z-2148-2014Synthes, Inc.
August 27, 2014ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, I…D-1548-2014US Compounding Inc
August 27, 2014Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laborator…D-1544-2014Trigen Laboratories, Inc.
August 27, 2014fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institut…D-1554-2014Healix Infusion Therapy, Inc.
August 27, 2014FISH FAMILY FARM INC. GRADE A PASTEURIZED HEAVY CREAM in glass pints, quarts, half-gallonsF-2349-2014Fish Family Farm
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2273-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packag…Z-2293-2014ICU Medical, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2274-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures…Z-2255-2014Ortho Development Corporation
August 27, 2014FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized a…F-2347-2014Fish Family Farm
August 27, 2014fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in…D-1553-2014Healix Infusion Therapy, Inc.
August 27, 2014GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiogr…Z-2291-2014GE Healthcare, LLC
August 27, 2014Jody's, Funfetti, Net Wt 7.5 oz (213 g) and 4 oz in clear cellophane bag.F-2329-2014Jody's Inc.
August 27, 2014PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile …Z-2289-2014Zimmer, Inc.
August 27, 2014PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pha…D-1545-2014Fresenius Kabi USA, LLC
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2283-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2286-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY…F-2342-2014Renfro Foods, Inc.
August 27, 2014Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top …Z-2296-2014Zimmer, Inc.
August 27, 2014fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDE…D-1555-2014Healix Infusion Therapy, Inc.
August 27, 2014Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE com…Z-2257-2014Ortho Development Corporation
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2277-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2287-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2278-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Synthes 3.0 MM TI Cannulated Screw Instrument and Implant SetZ-2265-2014Synthes, Inc.
August 27, 2014FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOM…F-2345-2014Fish Family Farm
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2281-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183,…D-1549-2014Doctor's Best, Inc.
August 27, 2014Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog N…Z-2260-2014Angiodynamics, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2271-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system use…Z-2238-2014Siemens Healthcare Diagnostics, Inc.
August 27, 2014Jody's, Breast Cancer Awareness Kettle Corn; Net Wt 3oz in clear cellophane bag.F-2331-2014Jody's Inc.
August 27, 2014Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO companyZ-2266-2014Vascutek, Ltd.
August 27, 2014Organic Carob Powder, Net Wt. 55lbs (25kg), Product Code: CAROB-100F-2332-2014BrandStorm Inc
August 27, 2014ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only…D-1542-2014Baxter Healthcare Corp
August 27, 2014American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Tota…F-2343-2014American Spoon Foods, Inc.
August 27, 2014Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plas…Z-2269-2014Gyrus Medical, Inc
August 27, 2014Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top …Z-2298-2014Zimmer, Inc.
August 27, 20146.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmerZ-2247-2014Zimmer, Inc.
August 27, 2014Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals In…D-1539-2014Mylan Pharmaceuticals Inc.
August 27, 2014Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthrop…Z-2253-2014Ortho Development Corporation
August 27, 2014Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packa…F-2335-2014Natural Grocers by Vitamin Cottage
August 27, 2014CaCoCo Superfood Drinking Chocolate; Original - Flavor Melody: Sweet, Playful, Perfectly…F-2338-2014CaCoCo, Inc.
August 27, 2014XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (32…F-2340-2014Renfro Foods, Inc.
August 27, 2014fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institut…D-1551-2014Healix Infusion Therapy, Inc.
August 27, 2014Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. pe…F-2344-2014D.A. Stein Culinary Group, LLC dba Brett Anthony Foods
August 27, 2014fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED …D-1552-2014Healix Infusion Therapy, Inc.
August 27, 2014Jody's, Freedom Funfetti; Net Wt 7.5 oz (213 g) in clear cellophane bag.F-2330-2014Jody's Inc.
August 27, 2014Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog N…Z-2261-2014Angiodynamics, Inc.

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