FDA recalls, May 2013: 519 published

146 different companies appear this month.

Risk classification: Class I: 83 · Class II: 377 · Class III: 59

Same month, other agencies:CPSC 22 recallsNHTSA 62 recalls

Recalls this month

DateProduct
May 8, 2013Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Ch…F-1370-2013Rich Products Corp
May 8, 2013Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plast…F-1354-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic…F-1365-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic …F-1359-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antaci…D-311-2013Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
May 8, 2013Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part…Z-1177-2013Maquet Cardiovascular Us Sales, Llc
May 8, 2013Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx o…D-308-2013Hospira Inc.
May 8, 2013Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC…D-309-2013Hospira Inc.
May 8, 2013CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended u…Z-1000-2013Trophy Sas
May 8, 2013Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and N…Z-1191-2013Medtronic Neuromodulation
May 8, 2013Strawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar,…F-1361-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: A…F-1373-2013Buffalo Trace Distillery
May 8, 2013Strawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexibl…F-1364-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013The GemStar Pump is a small and lightweight, single channel infusion device designed for …Z-1170-2013Hospira Inc.
May 8, 2013BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLE…F-1375-2013Buffalo Trace Distillery
May 8, 2013CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended us…Z-0999-2013Trophy Sas
May 8, 2013Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model num…Z-1171-2013Newport Medical Instruments Inc
May 8, 2013Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 …D-307-2013Carib Import & Export, Inc.
May 8, 2013Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391,…Z-1190-2013Medtronic Neuromodulation
May 8, 2013Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count b…D-303-2013Warner Chilcott Company LLC
May 8, 2013HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3…Z-1189-2013Philips Healthcare Inc.
May 8, 2013BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC …F-1374-2013Buffalo Trace Distillery
May 8, 2013Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria S…F-1367-2013Rich Products Corp
May 8, 2013Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexib…F-1357-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Spicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexibl…F-1356-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Bubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexibl…F-1362-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by…D-296-2013Jubilant Cadista Pharmaceuticals Inc.
May 8, 2013Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicat…Z-1187-2013Masimo Corporation
May 8, 2013Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Ther…Z-1182-2013Siemens Medical Solutions USA, Inc
May 8, 2013MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numb…Z-1192-2013Owens & Minor Distribution, Inc.
May 8, 2013Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bo…D-305-2013Warner Chilcott Company LLC
May 8, 2013GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0…Z-1209-2013GE Healthcare, LLC
May 8, 2013NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The Nx…Z-1214-2013NxStage Medical, Inc.
May 8, 2013Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians T…D-301-2013Physicians Total Care, Inc.
May 8, 2013GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight,…Z-1159-2013Hospira Inc.
May 8, 2013GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging …Z-1208-2013GE Healthcare, LLC
May 8, 2013Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imagi…Z-1212-2013GE Healthcare, LLC
May 8, 2013SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Cul…Z-1186-2013Discus Dental LLC
May 8, 2013Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt.…F-1368-2013Rich Products Corp
May 8, 2013CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage…Z-1094-2013Trophy Sas
May 8, 2013Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate S…Z-1210-2013Stryker Howmedica Osteonics Corp.
May 8, 2013Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitre…Z-1181-2013Vital Images, Inc.
May 8, 2013Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manu…D-306-2013West-ward Pharmaceutical Corp.
May 8, 2013Pina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingr…F-1360-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bact…Z-1183-2013B. Braun Medical, Inc.
May 8, 2013BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHAR…F-1376-2013Buffalo Trace Distillery
May 8, 2013Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, …F-1355-2013Paleteria Y Neveria La Rosita, LLC
May 8, 2013GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Di…Z-1188-2013GE Healthcare, LLC
May 8, 2013Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 6…D-310-2013Reckitt Benckiser Inc
May 1, 2013Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a divisi…D-278-2013Axium Healthcare Pharmacy dba Balanced Solutions Compounding

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