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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
Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15 Actavis Inc Class II Terminated 20150311
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1. Actavis Elizabeth LLC Class II Terminated 20150311
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6. Sun Pharma Global Fze Class II Terminated 20150304
Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets) Par Pharmaceutical Inc. Class II Terminated 20150304
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09 Hospira Inc. Class I Terminated 20150225
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045 Hospira Inc. Class I Terminated 20150225
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01. Hospira Inc. Class II Terminated 20150225
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Hospira Inc. Class I Terminated 20150225
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01. Hospira Inc. Class II Terminated 20150225
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. Hospira Inc. Class II Terminated 20150225
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection. AnazaoHealth Corporation Class II Terminated 20150218
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86 Sun Pharma Global Fze Class II Terminated 20150218
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 . Akorn, Inc. Class II Terminated 20150218
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8. Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20150211
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. Hospira Inc. Class I Terminated 20150211
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30 Hospira Inc. Class II Terminated 20150204
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. Baxter Healthcare Corp. Class II Terminated 20150204
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14. Valeant Pharmaceuticals North America LLC Class II Terminated 20150128
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Class II Terminated 20150128
CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20. Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Class II Terminated 20150128
3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144 3M Company/3m Espe Dental Products Class III Terminated 20150128
Total parenteral nutrition various strengths Walgreens Infusion Services Class II Terminated 20150128
L-cysteine various strengths Walgreens Infusion Services Class II Terminated 20150128
Immune globulin g human various strengths Walgreens Infusion Services Class II Terminated 20150128
Diphenhydramine 50 mg/ml vials Walgreens Infusion Services Class II Terminated 20150128
Dehydrated alcohol vials Walgreens Infusion Services Class II Terminated 20150128
Deferoxamine various strengths in normal saline Walgreens Infusion Services Class III Terminated 20150128
Magnesium sulfate various strengths in sodium chloride Walgreens Infusion Services Class II Terminated 20150128
Ranitidine various strengths in syringes Walgreens Infusion Services Class II Terminated 20150128
Thiamine 100 mg/ ml vials Walgreens Infusion Services Class II Terminated 20150128
Folic acid 1 mg/ 0.2 ml pre-drawn syringes Walgreens Infusion Services Class II Terminated 20150128
Dopamine various strengths in dextrose Walgreens Infusion Services Class II Terminated 20150128
Dobutamine various strengths in dextrose Walgreens Infusion Services Class II Terminated 20150128
Caspofungin various strengths in normal saline Walgreens Infusion Services Class II Terminated 20150128
Milrinone various strengths in dextrose Walgreens Infusion Services Class II Terminated 20150128
Acyclovir various strengths in normal saline Walgreens Infusion Services Class II Terminated 20150128
Tigecycline various strengths in normal saline Walgreens Infusion Services Class II Terminated 20150128
Linezolid various strengths in dextrose Walgreens Infusion Services Class II Terminated 20150128
Levofloxacin various strengths in normal saline Walgreens Infusion Services Class II Terminated 20150128
Ceftriaxone various strengths in normal saline Walgreens Infusion Services Class II Terminated 20150128
Daptomycin various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Gentamicin various strength in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Tobramycin various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Cefazolin various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Nafcillin various strengths in sterile water for injection bags Walgreens Infusion Services Class II Terminated 20150128
Meropenem various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Cefuroxime various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Vancomycin various strengths in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Piperacillin/ tazobactam various strength in normal saline bags Walgreens Infusion Services Class II Terminated 20150128
Ertapenem various strength in normal saline bags Walgreens Infusion Services Class II Terminated 20150128