Drug product
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
D-0265-2019
Product summary
- Event
- Event 81500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,502 bottles
- Official record key
drug-enforcement:D-0265-2019
Official wording
Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Code information: Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodiethylamine (NDEA
-
Manufacturing or process control
CGMP Deviations