Drug product
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
D-0108-2026
Product summary
- Event
- Event 97770
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,754 bottles.
- Official record key
drug-enforcement:D-0108-2026
Official wording
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Code information: Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Desipramine impurity
-
Manufacturing or process control
CGMP Deviations