clomiPRAMINE Hydrochloride Capsules USP 25 mg recall

Why it was recalled

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

Details

Product

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

Recalling company

Lupin Pharms

Classification

Class II

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

Nationwide.

Initiated

Jun 27, 2025

FDA report date

Jul 30, 2025