ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

FDA recall notice · announced October 5, 2022 · Leading Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot#: B14221, Exp. Date 02/2023
Quantity: 960 bottles (100 capsules)
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.