FDA recall D-1546-2022

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-08-23

Report date

2022-10-05

Termination date

2023-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1546-2022