Drug product
Losartan 50mg Tablet, 30 count each blister card.
D-1081-2019
Product summary
- Event
- Event 82532
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 blister cards of 30 = 990 tablets
- Official record key
drug-enforcement:D-1081-2019
Official wording
Reason: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Code information: 70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
Distribution pattern: Product was distributed to one sole customer, Miami, FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations