Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·4 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·12 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·210 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·300 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·516 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·103 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·600 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·117 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·280 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR ...
Injectable Drugs·25 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·580 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·800 affected·Oct 6, 2014
High RiskFDA
Hospira Inc.
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, I...
Injectable Drugs·200 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·5,483 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·43 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
Drugs·180 affected·Oct 6, 2014
High RiskFDA
Zimmer Surgical Inc
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam ...
Surgical Devices·828 affected·Oct 6, 2014
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Medical Devices·150 affected·Oct 6, 2014
High RiskFDA
Alcon Research, Ltd.
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsu...
Surgical Devices·6,597 affected·Oct 6, 2014
High RiskFDA
Perouse Medical
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain...
Surgical Devices·24,821 affected·Oct 6, 2014
High RiskFDA
Baxter Healthcare Corp.
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed ...
Medical Devices·96,458 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers...
Medical Devices·6 affected·Oct 6, 2014
High RiskFDA
Elekta, Inc.
Laksell Gamma Knife Perfexion
Medical Devices·181 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets an...
Medical Devices·47 affected·Oct 6, 2014
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoas...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindr...
Medical Devices·455 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part cove...
Medical Devices·5 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for th...
Medical Devices·0 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Medical Devices·1 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the ...
Medical Devices·15 affected·Oct 6, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the M...
Medical Devices·18 affected·Oct 6, 2014
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KW...
Medical Devices·1,873 affected·Oct 6, 2014
High RiskFDA
Wisconsin Pharmacal Company
CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharm...
Inhaled / Nasal Drugs·20,032 affected·Oct 3, 2014
High RiskFDA
Sagent Pharmaceuticals Inc
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for S...
Injectable Drugs·69,050 affected·Oct 3, 2014
High RiskFDA
Monteris Medical Corp
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the Neur...
Medical Devices·133 affected·Oct 3, 2014
High RiskFDA
Monteris Medical Corp
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroB...
Medical Devices·234 affected·Oct 3, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and...
Surgical Devices·5 affected·Oct 3, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgi...
Surgical Devices·311 affected·Oct 3, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT;...
Medical Devices·7,587 affected·Oct 3, 2014
Medium RiskFDA
Family Dollar Stores - Nc Distribution Center
Family Gourmet Long Grain Enriched White Rice in 32 oz. clear plastic bags (SKU: 1218898) and 80 oz. clear plastic bag (SKU: 1218870).
Food·423,505 affected·Oct 2, 2014
RecallFDA
Valeant Pharmaceuticals International
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 0...
Topical Drugs·1,663 affected·Oct 2, 2014
High RiskFDA
West-ward Pharmaceutical Corp.
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporate...
Oral Drugs·5,596 affected·Oct 2, 2014
RecallFDA
Sandoz, Inc
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratori...
Oral Drugs·6,336 affected·Oct 2, 2014
RecallFDA
Valeant Pharmaceuticals International
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016...
Topical Drugs·34,218 affected·Oct 2, 2014
High RiskFDA
Zimmer, Inc.
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Medical Implants·352 affected·Oct 2, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Medical Devices·11 affected·Oct 2, 2014