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Sciegen Pharmaceuticals Recalls
7 recalls on record · November 28, 2018 to March 8, 2023 · Drugs
Recalls by year
18
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 8, 2023DrugsFDA
Sciegen Pharmaceuticals Inc recalls Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge
Hazard: Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
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.