clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupi...
FDA Recall #D-0377-2025 — Class II — April 10, 2025
Product Description
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, 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 18-month long term stability study.
Recalling Firm
Lupin Pharmaceuticals Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2724 bottles
Distribution
USA nationwide
Code Information
Lot #: M300442, Exp Date: 6/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated