Drug product
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.
D-0272-2019
Product summary
- Event
- Event 81458
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,194 HDPE bottles
- Official record key
drug-enforcement:D-0272-2019
Official wording
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodimethylamine (NDEA
-
Manufacturing or process control
CGMP Deviations