Drug product
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
D-0112-2026
Product summary
- Event
- Event 97770
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,750 bottles.
- Official record key
drug-enforcement:D-0112-2026
Official wording
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Code information: Lot#: 18035739, Exp. Date: 11/30/2025
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Desipramine impurity
-
Manufacturing or process control
CGMP Deviations