RecallDepth
Class II Terminated

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

Company
Lupin Pharmaceuticals Inc.
Recall Initiated
April 10, 2025
Posted
April 30, 2025
Recall Number
D-0377-2025
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2724 bottles
Firm Location
Naples, FL, United States

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.

Distribution

USA nationwide

Lot / Code Info

Lot #: M300442, Exp Date: 6/30/2025

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