Drug product
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
D-1546-2022
Product summary
- Event
- Event 90853
- Status
- Terminated
- Classification
- Class III
- Quantity
- 960 bottles (100 capsules)
- Official record key
drug-enforcement:D-1546-2022
Official wording
Reason: Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Code information: Lot#: B14221, Exp. Date 02/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent