Drug product
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
D-0534-2023
Product summary
- Event
- Event 91880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,804 bottles
- Official record key
drug-enforcement:D-0534-2023
Official wording
Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Code information: Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations