DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

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

ProductFirmClassificationStatusReport date
Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 Forest Pharmaceuticals Inc Class III Terminated 20140212
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH Central Shared Services dba Parallon Class II Terminated 20140212
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 Teva Pharmaceuticals USA, Inc. Class II Terminated 20140212
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) Actavis Inc Class II Terminated 20140212
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 Greenstone Llc Class III Terminated 20140212
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 Pfizer Inc. Class III Terminated 20140212
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 Baxter Healthcare Corp. Class I Terminated 20140212
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. Insight Instruments, Inc. Class II Terminated 20140212
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Fusion Pharmaceuticals, LLC Class II Terminated 20140212
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 B. Braun Medical Inc Class I Terminated 20140212
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01. Watson Laboratories Inc Class II Terminated 20140205
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244 NuVision Pharmacy, Inc. Class I Terminated 20140205
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 NuVision Pharmacy, Inc. Class I Terminated 20140205
Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com IQ Formulations, LLC Class I Terminated 20140205
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Alexion Pharmaceuticals, Inc. Class I Terminated 20140205
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501. Humco Holding Group, Inc Class II Terminated 20140205
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6. SS Wholesale Inc. dba Jobbers Wholesale Class I Terminated 20140205
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2. SS Wholesale Inc. dba Jobbers Wholesale Class I Terminated 20140205
Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. SS Wholesale Inc. dba Jobbers Wholesale Class I Terminated 20140205
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. Fougera Pharmaceuticals Inc. Class III Terminated 20140205
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880 Actavis Inc Class III Terminated 20140205
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02. Wockhardt Usa Inc. Class II Terminated 20140205
ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. The Mentholatum Co. Class II Terminated 20140205
ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. The Mentholatum Co. Class II Terminated 20140205
ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. The Mentholatum Co. Class II Terminated 20140205
ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. The Mentholatum Co. Class II Terminated 20140205
ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. The Mentholatum Co. Class II Terminated 20140205
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59. Hospira Inc. Class II Terminated 20140205
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05 Hospira Inc. Class II Terminated 20140205
METHAZOLAMIDE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781107101. Aidapak Services, LLC Class II Terminated 20140129
PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781104901. Aidapak Services, LLC Class II Terminated 20140129
TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781103001. Aidapak Services, LLC Class II Terminated 20140129
CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840. Aidapak Services, LLC Class II Terminated 20140129
PERPHENAZINE, Tablet, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00630506221. Aidapak Services, LLC Class II Terminated 20140129
sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121. Aidapak Services, LLC Class II Terminated 20140129
PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221. Aidapak Services, LLC Class II Terminated 20140129
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832. Aidapak Services, LLC Class II Terminated 20140129
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821. Aidapak Services, LLC Class II Terminated 20140129
PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721. Aidapak Services, LLC Class II Terminated 20140129
PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321. Aidapak Services, LLC Class II Terminated 20140129
OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521. Aidapak Services, LLC Class II Terminated 20140129
OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521 Aidapak Services, LLC Class II Terminated 20140129
MODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603466216. Aidapak Services, LLC Class II Terminated 20140129
methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603459321. Aidapak Services, LLC Class II Terminated 20140129
HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919. Aidapak Services, LLC Class II Terminated 20140129
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121. Aidapak Services, LLC Class II Terminated 20140129
ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603254421. Aidapak Services, LLC Class II Terminated 20140129
BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516. Aidapak Services, LLC Class II Terminated 20140129
ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00597000160. Aidapak Services, LLC Class II Terminated 20140129
MINOCYCLINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569550. Aidapak Services, LLC Class II Terminated 20140129