Drug product
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
D-0271-2019
Product summary
- Event
- Event 81458
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,760 HDPE bottles
- Official record key
drug-enforcement:D-0271-2019
Official wording
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information: 60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-19
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodimethylamine (NDEA
-
Manufacturing or process control
CGMP Deviations