FDA recalls, September 2013: 423 published

152 different companies appear this month.

Risk classification: Class I: 43 · Class II: 358 · Class III: 22

Same month, other agencies:CPSC 19 recallsNHTSA 50 recalls

Recalls this month

DateProduct
September 18, 2013EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,…D-953-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR…D-980-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Pr…Z-2195-2013Sybron Dental Specialties
September 18, 2013"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures wh…Z-2189-2013Edwards Lifesciences, LLC
September 18, 2013Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies…Z-2123-2013Siemens Healthcare Diagnostics, Inc.
September 18, 2013TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, F…D-1003-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 …Z-2173-2013Roche Molecular Systems, Inc.
September 18, 2013Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Syn…Z-2128-2013Siemens Healthcare Diagnostics, Inc.
September 18, 2013B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY…D-936-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: Micr…Z-2125-2013Siemens Healthcare Diagnostics, Inc.
September 18, 2013K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate…D-1036-2013Qualitest Pharmaceuticals
September 18, 2013TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, R…D-1008-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERI…D-1011-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONL…D-1018-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO an…D-970-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multip…D-1026-2013South Coast Specialty Compounding, Inc.
September 18, 2013CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, ST…D-1017-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, Univer…D-1022-2013University Compounding Pharmacy
September 18, 2013GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE …D-962-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for…Z-2191-2013Lumenis, Inc.
September 18, 2013ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnos…Z-2172-2013Siemens Healthcare Diagnostics, Inc
September 18, 2013DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND …D-947-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8F-1878-2013KDK Management, Inc., dba Bubbles Baking Co.
September 18, 2013L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER…D-972-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ON…D-982-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used…Z-2164-2013B Braun Medical, Inc.
September 18, 2013ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERIL…D-937-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERIL…D-967-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,…D-938-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Phar…D-1021-2013University Compounding Pharmacy
September 18, 2013Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda …Z-2161-2013GE Healthcare, LLC
September 18, 2013Surgical microscope The device is used to improve the visibility of objects through ma…Z-2177-2013Leica Microsystems (Schweiz) Ag
September 18, 2013Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227…D-1032-2013Wellness Pharmacy, Inc.
September 18, 2013PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY, …D-993-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ON…D-981-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVE…D-985-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1…D-1033-2013Wellness Pharmacy, Inc.
September 18, 2013HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The Hemo…Z-2190-2013HemoCue AB
September 18, 2013Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Rea…F-1879-2013Reaction Nutrition LLC
September 18, 2013Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used…Z-2175-2013B Braun Medical, Inc.
September 18, 2013OPERON D850 Surgical Table Product Usage: Surgical TableZ-2168-2013Berchtold Corp.
September 18, 2013HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and …D-969-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERI…D-939-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx…Z-2192-2013Becton Dickinson & Company
September 18, 2013ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ON…D-1012-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Outlook Safety Infusion System Burette Set. For intravenous fluid administration.Z-2166-2013B. Braun Medical, Inc.
September 18, 2013SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, …D-998-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compoundin…D-1020-2013University Compounding Pharmacy
September 18, 2013SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ…D-1000-2013Beacon Hill Medical Pharmacy, P.C.
September 18, 2013BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX …D-942-2013Beacon Hill Medical Pharmacy, P.C.

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