Sciegen Pharmaceuticals recalls

FDA enforcement reports naming Sciegen Pharmaceuticals Inc as the recalling firm.

Recall reports: 7
Class I (serious): 0
Most recent report: Mar 8, 2023

Severity

Mar 8, 2023Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGe…Drug · Sciegen Pharmaceuticals IncPresence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.Class III
Nov 28, 2018Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II
Nov 28, 2018Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II
Nov 28, 2018Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b)…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II
Nov 28, 2018GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-co…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II
Nov 28, 2018GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-cou…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II
Nov 28, 2018GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen…Drug · Sciegen Pharmaceuticals IncCGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.Class II