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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
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026) Perrigo Company PLC Class III Terminated 20151230
HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Oasis Medical, Inc. Class III Terminated 20151230
HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Oasis Medical, Inc. Class III Terminated 20151230
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 Oasis Medical, Inc. Class III Terminated 20151230
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98 Teva Pharmaceutical Industries Class III Terminated 20151223
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Pfizer Inc. Class III Terminated 20151216
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 GlaxoSmithKline, LLC Class II Terminated 20151216
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251. Steris Corp Class II Terminated 20151216
Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57 RemedyRepack Inc. Class II Terminated 20151216
Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01 RemedyRepack Inc. Class II Terminated 20151216
Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01 RemedyRepack Inc. Class II Terminated 20151216
Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16 RemedyRepack Inc. Class II Terminated 20151216
Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02 RemedyRepack Inc. Class II Terminated 20151216
Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03 RemedyRepack Inc. Class II Terminated 20151216
Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08 RemedyRepack Inc. Class II Terminated 20151216
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. Golden State Medical Supply Inc. Class III Terminated 20151216
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10. Golden State Medical Supply Inc. Class III Terminated 20151216
HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Life Science Pharmacy Inc Class II Terminated 20151209
Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53 Northwind Pharmaceuticals LLC Class III Terminated 20151209
Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209
Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Western Drug Class II Terminated 20151209