FDAFDA · Food and drugs·Recall number D-0270-2019
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.
Published November 28, 2018 · Recall initiated: October 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Sciegen Pharmaceuticals Inc
- Distributor
- Nationwide
- Lot
- 60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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