FDA recalls, September 2014: 547 published

132 different companies appear this month.

Risk classification: Class I: 319 · Class II: 216 · Class III: 12

Same month, other agencies:FSIS 8 recallsNHTSA 96 recalls

Recalls this month

DateProduct
September 3, 2014Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the manufacture of cheese dipF-2358-2014Custom Ingredients LLC
September 3, 2014H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation KitZ-2541-2014Smiths Medical ASD, Inc.
September 3, 2014Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Phar…D-1565-2014Pharmakon Pharmaceuticals
September 3, 2014CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterili…Z-2243-2014Cook Inc.
September 3, 2014Cordis EMPIRA RX PTCA Dilatation CatheterZ-2557-2014Cordis Corporation
September 3, 2014Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese…F-2350-2014Custom Ingredients LLC
September 3, 2014Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coc…F-2381-2014Florimont, Inc.
September 3, 2014Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaii…F-2390-2014Florimont, Inc.
September 3, 2014MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TXD-1563-2014Abrams Royal Pharamacy
September 3, 2014Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of c…F-2356-2014Custom Ingredients LLC
September 3, 2014ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC…F-2393-2014Health Matters America Inc.
September 3, 2014Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese d…F-2363-2014Custom Ingredients LLC
September 3, 2014All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TXD-1564-2014Abrams Royal Pharamacy
September 3, 2014Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Label…D-1566-2014Pharmakon Pharmaceuticals
September 3, 2014Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Ph…D-1557-2014Mylan Pharmaceuticals Inc.
September 3, 2014Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the manufacture of cheese dipF-2353-2014Custom Ingredients LLC
September 3, 2014Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 453g; DISTRIBUTED BY Nat…F-2376-2014Creative Foodworks, Inc
September 3, 2014Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verig…Z-2559-2014Nanosphere, Inc.
September 3, 2014Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument.…Z-2543-2014Zimmer, Inc.
September 3, 2014Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz.…F-2389-2014Florimont, Inc.
September 3, 2014DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTER…F-2370-2014Consolidated Mills, Inc
September 3, 2014All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture…F-2361-2014Custom Ingredients LLC
September 3, 2014Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145…Z-2552-2014Zimmer, Inc.
September 3, 2014Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 454g; DISTRIBUTED BY H…F-2375-2014Creative Foodworks, Inc
September 3, 2014Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavor…F-2378-2014Florimont, Inc.
September 3, 2014All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture …F-2357-2014Custom Ingredients LLC
September 3, 2014RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Ma…F-2401-2014Beta Labs
September 3, 2014RegeneSlim Appetite Control, 2 capsules/ packet, Dietary SupplementF-2403-2014Regeneca, Inc
September 3, 2014Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of cheese d…F-2368-2014Custom Ingredients LLC
September 3, 2014Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of c…F-2365-2014Custom Ingredients LLC
September 3, 2014Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agav…F-2384-2014Florimont, Inc.
September 3, 2014PriceRite Spring Water Net 1 GAL (3.78 L) Distributed by P.R.R.C. Inc. 5000 Riverside Dri…F-2320-2014Readington Farms Inc.
September 3, 2014Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture…F-2369-2014Custom Ingredients LLC
September 3, 2014PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Lab…F-2400-2014Beta Labs
September 3, 2014H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotrachea…Z-2538-2014Smiths Medical ASD, Inc.
September 3, 2014Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5…F-2391-2014Florimont, Inc.
September 3, 2014Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candie…F-2386-2014Florimont, Inc.
September 3, 2014H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotrac…Z-2537-2014Smiths Medical ASD, Inc.
September 3, 2014Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to…Z-2553-2014Siemens Healthcare Diagnostics, Inc.
September 3, 2014Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dipF-2364-2014Custom Ingredients LLC
September 3, 2014Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-pac…F-2402-2014Honey Heaven Wholesale, Inc.
September 3, 2014Cordis EMPIRA NC RX PTCA Dilatation CatheterZ-2556-2014Cordis Corporation
September 3, 2014Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not…D-1484-2014Novel Laboratories, Inc.
September 3, 2014The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate…Z-2555-2014Thermedx LLC
September 3, 2014French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture o…F-2352-2014Custom Ingredients LLC
September 3, 20144001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal…Z-2536-2014Smiths Medical ASD, Inc.
September 3, 2014LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Li…D-1562-2014Central Admixture Pharmacy Services, Inc.
September 3, 2014Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dipF-2354-2014Custom Ingredients LLC
September 3, 2014Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA E…Z-2547-2014Zimmer, Inc.
September 3, 2014SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To…F-2373-2014Creative Foodworks, Inc

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