FDA Recall
Terminated
Historical recordClass III
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China
by Freedom Pharmaceuticals Inc
- Reason
- Subpotent Drug
- Published
- January 13, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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)
by Perrigo Company PLC
- Reason
- Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
- Published
- December 30, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Oasis Medical, Inc.
- Reason
- Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Published
- December 30, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Oasis Medical, Inc.
- Reason
- Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Published
- December 30, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Oasis Medical, Inc.
- Reason
- Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Published
- December 30, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by Teva Pharmaceutical Industries
- Reason
- Labeling: Incorrect or Missing Lot AND/OR Exp Date.
- Published
- December 23, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Pfizer Inc.
- Reason
- Failed Dissolution Specification
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by GlaxoSmithKline, LLC
- Reason
- Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
- Published
- December 16, 2015
- Distribution
- MS and VT
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by RemedyRePack Inc.
- Reason
- Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- December 16, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
by Life Science Pharmacy Inc
- Reason
- Penicillin Cross Contamination: potentially contaminated with penicillin
- Published
- December 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
by Life Science Pharmacy Inc
- Reason
- Penicillin Cross Contamination: potentially contaminated with penicillin
- Published
- December 9, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
by Life Science Pharmacy Inc
- Reason
- Penicillin Cross Contamination: potentially contaminated with penicillin
- Published
- December 9, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.