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
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxi...
Medical Implants·261,109 affected·Jun 3, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5...
Diagnostic Devices·76 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump conn...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Finger Lakes Farmstead Cheese Company Llc
Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES...
Dairy·5 affected·May 31, 2013
High RiskFDA
Finger Lakes Farmstead Cheese Company Llc
Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES...
Dairy·7 affected·May 31, 2013
High RiskFDA
Oskri Corp.
Box: Oskri, Sesame Bars Date Syrup, Gluten Free, Halal Vegetarian, 5 Bars each 1.9 oz (53g) total weight 9.5 oz (265g), UPC 6 66016 4005...
Food·42 affected·May 31, 2013
CriticalFDA
International Desserts And Delicacies
Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:"unc...
Bakery & Grains·540 affected·May 31, 2013
Medium RiskFDA
Pfizer Inc.
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth P...
Oral Drugs·432,657 affected·May 31, 2013
Medium RiskFDA
Pfizer Inc.
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth P...
Oral Drugs·135,520 affected·May 31, 2013
CriticalFDA
Abrams Royal Pharmacy
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, ...
Injectable Drugs·1,100 affected·May 31, 2013
RecallFDA
Pfizer Inc
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500...
Oral Drugs·5,410 affected·May 31, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is...
Medical Devices·119 affected·May 31, 2013
High RiskFDA
Greatbatch Medical
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane ...
Medical Devices·550 affected·May 31, 2013
High RiskFDA
Cheryls
Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin c...
Dairy·10,588 affected·May 30, 2013
High RiskFDA
Sandoz Incorporated
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sa...
Injectable Drugs·297,200 affected·May 30, 2013
RecallFDA
Pharmalucence, Inc.
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and ...
Injectable Drugs·17,260 affected·May 30, 2013
High RiskFDA
Terumo Medical Corporation
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the i...
Diagnostic Devices·20 affected·May 30, 2013
High RiskFDA
Deroyal Industries Inc
GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Surgical Devices·87 affected·May 30, 2013
High RiskFDA
Terumo Medical Corporation
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a v...
Surgical Devices·550 affected·May 30, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for...
Medical Devices·7 affected·May 30, 2013
High RiskFDA
Exactech, Inc.
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d...
Medical Devices·57 affected·May 30, 2013
CriticalFDA
Stryker Spine
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline...
Medical Devices·1,536 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Hill-rom, Inc.
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The ...
Surgical Devices·4,121 affected·May 30, 2013
CriticalFDA
Conagra Inc
Lightlife Farmer's Market Veggie Burgers, meat free, 12 oz/4-count bag, packaged in 5/12 oz-bag/cartons. Distributed By: Lightlife Foods,...
Meat & Poultry·66,805 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·5 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Bi mix, compounded by Olympia Pharmacy, Orlando, FL
Drugs·4 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL
Drugs·1 affected·May 29, 2013