Sciegen Pharmaceuticals recalls
Sciegen Pharmaceuticals appears in 7 official U.S. recall notices indexed by RecallRadar, most recently on 2023-03-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 7 |
|---|---|
| Published | 2018-11-28 to 2023-03-08 |
| By agency | FDA Drug (7) |
| By classification | Class II (6), Class III (1) |
| By status | terminated (7) |
| Distribution named in notices | US |
Recalls
- Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50…
FDA Drug · Class III · 2023-03-08 · Sciegen Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. - GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured…
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. - GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured…
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. - Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufac…
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. - Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufa…
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. - GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. - Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manu…
FDA Drug · Class II · 2018-11-28 · Sciegen Pharmaceuticals
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.