IRBESARTAN Tablets recalled over manufacturing violations
- Recall date
- November 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 117…
- Recall number
- D-0263-2019
- FDA classification
- Class II
- Brand / firm
- Golden State Medical Supply Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (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
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
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