FDA recalls, June 2013: 450 published

138 different companies appear this month.

Risk classification: Class I: 59 · Class II: 361 · Class III: 30

Same month, other agencies:CPSC 26 recallsNHTSA 52 recalls

Recalls this month

DateProduct
June 12, 2013Massive Muscle Gainer- Weight Gainer¿ Dutch Chocolate¿10 LBS: Whey Protein/Isolate, Soy L…F-1494-2013Chemi- Source Inc, Nutra Pak
June 12, 2013Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution w…D-584-2013Pentec Health
June 12, 2013Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Sho…D-551-2013THE COMPOUNDING SHOP, INC.
June 12, 2013Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Pro…Z-1498-2013Stryker Instruments Div. of Stryker Corporation
June 12, 2013E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width TechnologyZ-1480-2013Kreg Medical Inc.
June 12, 2013Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC…D-543-2013TG United, Inc.
June 12, 2013Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use;…Z-1504-2013Stryker Instruments Div. of Stryker Corporation
June 12, 2013Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. …Z-1455-2013Symbios Medical Products, LLC
June 12, 2013Smiling Hill Farm brand Butter, 1/2 lb, 5 lb; Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variabl…F-1477-2013Smiling Hill Farm, Inc. dba Silvery Moon Creamery
June 12, 2013Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to mode…Z-1466-2013Hill-Rom, Inc.
June 12, 2013I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intende…Z-1445-2013I-Flow LLC
June 12, 20138 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: I…Z-1442-2013Intuitive Surgical, Inc.
June 12, 2013Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... fo…Z-1454-2013Symbios Medical Products, LLC
June 12, 2013Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding S…D-567-2013THE COMPOUNDING SHOP, INC.
June 12, 2013FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXST…Z-1511-2013Cordis Corporation
June 12, 2013ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in…Z-1513-2013Siemens Healthcare Diagnostics, Inc
June 12, 2013Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/C…F-1480-2013Chemi- Source Inc, Nutra Pak
June 12, 2013Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position impl…Z-1482-2013SpineFrontier, Inc.
June 12, 2013Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in o…Z-1369-2013Shimadzu Medical Systems
June 12, 2013White Farm Enriched White Bread. 16 oz (454g), 9pc/box. UPC 0 10314 10002 0. The labe…F-1474-2013LL Bakery, Inc.
June 12, 2013Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to…Z-1462-2013Symbios Medical Products, LLC
June 12, 2013Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured …D-517-2013TG United, Inc.
June 12, 2013Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured …D-529-2013TG United, Inc.
June 12, 2013Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single us…Z-1497-2013Stryker Instruments Div. of Stryker Corporation
June 12, 2013Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; …Z-1494-2013Stryker Instruments Div. of Stryker Corporation
June 12, 2013Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St.…D-568-2013THE COMPOUNDING SHOP, INC.
June 12, 2013BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: P…D-524-2013TG United, Inc.
June 12, 2013Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr )…Z-1461-2013Symbios Medical Products, LLC
June 12, 2013Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instr…Z-1484-2013Zimmer Surgical Inc
June 12, 2013Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versap…Z-1472-2013Covidien LP
June 12, 2013BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-0…D-526-2013TG United, Inc.
June 12, 2013AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl …D-503-2013TG United, Inc.
June 12, 2013Metabolic Whey - Vanilla¿5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin …F-1495-2013Chemi- Source Inc, Nutra Pak
June 12, 2013Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solu…D-593-2013Pentec Health
June 12, 2013Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5L…Z-1467-2013Covidien LP
June 12, 2013Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trige…D-541-2013TG United, Inc.
June 12, 2013da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Syst…Z-1464-2013Intuitive Surgical, Inc.
June 12, 2013UPC6-09492 72050-4, 72053-5 , Metabolic Whey - Rich Chocolate¿5 LBS, 10 LBS : Whey Prote…F-1483-2013Chemi- Source Inc, Nutra Pak
June 12, 2013Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactur…D-536-2013TG United, Inc.
June 12, 2013FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXST…Z-1510-2013Cordis Corporation
June 12, 2013FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Bili…Z-1509-2013Cordis Corporation
June 12, 2013Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmace…D-578-2013Teva Pharmaceuticals USA, Inc.
June 12, 2013All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/…F-1478-2013Chemi- Source Inc, Nutra Pak
June 12, 2013AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Va…D-511-2013TG United, Inc.
June 12, 2013FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Bili…Z-1507-2013Cordis Corporation
June 12, 20131% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One…F-1473-2013HP Hood LLC
June 12, 2013Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G,…Z-1451-2013Maytex Corp
June 12, 2013SlingBar Wide 670. Designed to meet the needs for lifting humans.Z-1475-2013Hill-Rom, Inc.
June 12, 2013Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by …D-556-2013THE COMPOUNDING SHOP, INC.
June 12, 2013Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used a…Z-1478-2013Bion Enterprises Ltd

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