Recall D-0537-2025

US Class II Terminated · initiated 2025-06-27

Recalling firm

Lupin Pharmaceuticals Inc., FL

Product

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Reason for recall

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

← All recalls