Leading Pharma, LLC: Drug Recall

Recall #D-1546-2022 · 08/23/2022

Class III: Low Risk

Recall Details

Recall Number
D-1546-2022
Classification
Class III
Product Type
Drug
Recalling Firm
Leading Pharma, LLC
Status
Terminated
Date Initiated
08/23/2022
Location
Fairfield, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
960 bottles (100 capsules)

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.