Recall: D-1546-2022

Class III - Minor Violations

Class IIIClassification

2022-08-23Initiated

TerminatedStatus

Leading Pharma, LLCFirm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.