FDA-Drug2018-11-28Class II
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.
Sciegen Pharmaceuticals Inc
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Sold states
Nationwide
Affected count
3,835 HDPE bottles
Manufactured in
89 Arkay Dr, N/A, Hauppauge, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2019Don't want to check this manually?
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