FDAFDA · Food and drugs·Recall number D-0272-2019
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 by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
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
- 60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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