Drug product
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
D-1282-2019
Product summary
- Event
- Event 82832
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,668 HDPE bottles
- Official record key
drug-enforcement:D-1282-2019
Official wording
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Code information: GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020
Distribution pattern: IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations