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 5, 2013Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-se…F-1461-2013The Sourdough: A European Bakery Inc.
June 5, 2013Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic …Z-1434-2013Heart Sync, Inc
June 5, 201350 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of sp…Z-1410-2013Spinal Solutions, LLC
June 5, 2013PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,D-457-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Cannula 8MM Regular. Provides the means of introduction and placement of an instrument…Z-1427-2013Intuitive Surgical, Inc.
June 5, 2013EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usag…Z-1373-2013Nephron Pharmaceuticals Corp.
June 5, 2013Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062F-1464-2013Talenti Gelato
June 5, 2013Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweim…Z-1385-2013Orthopedic Alliance LLC
June 5, 2013Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,D-461-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,D-492-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: …Z-1406-2013Angiodynamics, Inc.
June 5, 2013BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic…Z-1423-2013Becton Dickinson & Co.
June 5, 2013Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,D-454-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plung…Z-1387-2013Orthovita, Inc., dBA Stryker Orthobiologics.
June 5, 20138mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model…Z-1432-2013Intuitive Surgical, Inc.
June 5, 2013PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,D-474-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only,…D-500-2013Mylan Pharmaceuticals Inc.
June 5, 2013Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiratio…D-484-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci T…Z-1426-2013Intuitive Surgical, Inc.
June 5, 2013Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Can…F-1449-2013Pecan Deluxe Candy Company
June 5, 20137th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OKF-1453-20137-Eleven Stores of Oklahoma
June 5, 2013Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamo…Z-1394-2013Orthovita, Inc., dBA Stryker Orthobiologics.
June 5, 2013Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,D-473-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufac…F-1452-2013Pecan Deluxe Candy Company
June 5, 2013Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiratio…D-455-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,D-462-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,D-465-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 201345 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of sp…Z-1409-2013Spinal Solutions, LLC
June 5, 2013Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,D-490-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 20138mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model…Z-1431-2013Intuitive Surgical, Inc.
June 5, 2013Whole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the ret…F-1462-2013The Sourdough: A European Bakery Inc.
June 5, 2013Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,D-470-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Man…F-1448-2013Pecan Deluxe Candy Company
June 5, 201350 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spin…Z-1413-2013Spinal Solutions, LLC
June 5, 2013Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A955…Z-1400-2013Beckman Coulter Inc.
June 5, 2013GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DAT…F-1465-2013Arthur Schuman Midwest LLC
June 5, 2013***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.Z-1377-2013The Anspach Effort, Inc.
June 5, 2013Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long,…Z-1382-2013Orthopedic Alliance LLC
June 5, 2013PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,D-459-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ba…Z-1386-2013Orthopedic Alliance LLC
June 5, 2013da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive S…Z-1429-2013Intuitive Surgical, Inc.
June 5, 2013U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coat…Z-1381-2013Orthopedic Alliance LLC
June 5, 2013HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,D-476-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover acc…Z-1425-2013Intuitive Surgical, Inc.
June 5, 2013Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,D-485-2013Nora Apothecary and Alternative Therapies, Inc.
June 5, 2013Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Del…F-1451-2013Pecan Deluxe Candy Company
June 5, 2013Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 …F-1463-2013National Food & Beverage, Inc
June 5, 2013Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic…Z-1408-2013Merit Medical Systems, Inc.
June 5, 2013Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo …Z-1401-2013Alere San Diego, Inc.
June 5, 2013Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,D-488-2013Nora Apothecary and Alternative Therapies, Inc.

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