clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Sui...
FDA Recall #D-0537-2025 — Class II — June 27, 2025
Product Description
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,724 bottles
Distribution
Nationwide.
Code Information
Lot # M300464, exp. date June, 2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated