FDA-Drug2022-10-05Class III

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

Leading Pharma, LLC
Hazard

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

Sold states
Nationwide within the United States
Affected count
960 bottles (100 capsules)
Manufactured in
3 Oak Rd, N/A, Fairfield, NJ, United States
Products
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Official notice

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

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