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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Med Prep Consulting, Inc. Class II Terminated 20130731
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Med Prep Consulting, Inc. Class I Terminated 20130731
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Mobius Therapeutics LLC Class I Terminated 20130731
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 Pharmalucence, Inc. Class III Terminated 20130731
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin Bayer HealthCare Pharmaceuticals Inc. Class III Terminated 20130724
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. Apotex Corp. Class I Terminated 20130724
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 Sandoz Incorporated Class II Terminated 20130724
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. Fresenius Kabi USA, LLC Class II Terminated 20130724
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Teva Pharmaceuticals USA, Inc. Class III Terminated 20130724
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01 American Health Packaging Class II Terminated 20130724
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511. Church & Dwight Inc Class II Terminated 20130724
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411. Church & Dwight Inc Class II Terminated 20130724
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311. Church & Dwight Inc Class II Terminated 20130724
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211. Church & Dwight Inc Class II Terminated 20130724
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111. Church & Dwight Inc Class II Terminated 20130724
Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Vitamin A/D3/E Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Trimix, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Quadmix, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Praziquantel 56.8mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717
Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lowlite Investments, Inc. D/B/A Olympia Pharmacy Class II Ongoing 20130717