November 28, 2018DrugsFDA
Ecolab Inc recalls Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St
Hazard: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
November 28, 2018DrugsFDA
Ecolab Inc recalls Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street
Hazard: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
November 28, 2018DrugsFDA
AMERICAN HEALTH PACKAGING recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Heal
Hazard: Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge,
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 693
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-0
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 28, 2018DrugsFDA
L. Perrigo Company recalls Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-
Hazard: Presence of foreign substance: Product found to contain metal particles.
November 28, 2018DrugsFDA
Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, M
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, M
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
November 28, 2018DrugsFDA
Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 1178
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
November 21, 2018DrugsFDA
Epic Products, LLC recalls Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-coun
Hazard: Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
November 21, 2018DrugsFDA
Takeda Development Center Americas, Inc. recalls AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD
Hazard: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
November 21, 2018DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical,
Hazard: Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
November 21, 2018DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ
Hazard: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
November 21, 2018DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120
Hazard: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
November 21, 2018DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 F
Hazard: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
November 21, 2018DrugsFDA
Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northsta
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; ND
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01);
Hazard: Cross Contamination with Other Products
November 21, 2018DrugsFDA
Kadesh International recalls puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Hazard: Non-Sterility: Product manufactured under non-sterile production conditions.
November 21, 2018DrugsFDA
Eli Lilly & Co recalls ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC
Hazard: Labeling: Missing label; potential for missing primary container label on the vial.
November 21, 2018DrugsFDA
Zero Xtreme USA recalls Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Hazard: Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
November 21, 2018DrugsFDA
RemedyRepack Inc. recalls Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, ND
Hazard: Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
November 21, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA,
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing