GSMS Irbesartan Tablets recalled over manufacturing violations
- Recall date
- October 29, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge,…
- Recall number
- D-0270-2019
- FDA classification
- Class II
- Brand / firm
- Sciegen Pharmaceuticals Inc
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GSMS 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.
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