PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 5, 2022 Initiated: August 23, 2022 #D-1546-2022

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

Reason for Recall

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

Details

Recalling Firm
Leading Pharma, LLC
Units Affected
960 bottles (100 capsules)
Distribution
Nationwide within the United States
Location
Fairfield, NJ

Frequently Asked Questions

What product was recalled?
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01. Recalled by Leading Pharma, LLC. Units affected: 960 bottles (100 capsules).
Why was this product recalled?
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Which agency issued this recall?
This recall was issued by the FDA Drug on October 5, 2022. Severity: Low. Recall number: D-1546-2022.