Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIGSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIGSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIGSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIWestminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIWestminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugSciegen Pharmaceuticals IncClass IIWestminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- 2018-11-28FDA-DrugL. Perrigo CompanyClass IIAntacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG health brand NDC: 55910-717-72, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072]
Presence of foreign substance: Product found to contain metal particles.
- 2018-11-28FDA-DrugGolden State Medical Supply Inc.Class IIIRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
- 2018-11-28FDA-DrugGolden State Medical Supply Inc.Class IIIRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
- 2018-11-28FDA-DrugGolden State Medical Supply Inc.Class IIIRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
- 2018-11-21FDA-DrugEpic Products, LLCClass IEuphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
- 2018-11-21FDA-DrugTakeda Development Center Americas, Inc.Class IIIAMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
- 2018-11-21FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIIMegestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
- 2018-11-21FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIchildren's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- 2018-11-21FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIchildren's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- 2018-11-21FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- 2018-11-21FDA-DrugSandoz IncClass IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
Cross Contamination with Other Products
- 2018-11-21FDA-DrugSandoz IncClass IIIsosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Cross Contamination with Other Products
- 2018-11-21FDA-DrugSandoz IncClass IIIsosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
Cross Contamination with Other Products
- 2018-11-21FDA-DrugSandoz IncClass IIIsosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
Cross Contamination with Other Products
- 2018-11-21FDA-DrugSandoz IncClass IIIsosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Cross Contamination with Other Products
- 2018-11-21FDA-DrugSandoz IncClass IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Cross Contamination with Other Products
- 2018-11-21FDA-DrugKadesh InternationalClass Ipuriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Non-Sterility: Product manufactured under non-sterile production conditions.
- 2018-11-21FDA-DrugEli Lilly & CoClass IIIERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23
Labeling: Missing label; potential for missing primary container label on the vial.
- 2018-11-21FDA-DrugZero Xtreme USAClass IIZero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
- 2018-11-21FDA-DrugRemedyRepack Inc.Class IIIMetoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
- 2018-11-21FDA-DrugTeva Pharmaceuticals USAClass IIAlprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- 2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class IIITadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51
Labeling Not Elsewhere Classified: Misbranding.
- 2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class IIITadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
Labeling Not Elsewhere Classified: Misbranding.
- 2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class IIIProgesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74
Labeling Not Elsewhere Classified: Misbranding.
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief