FDAHealthApril 10, 2025

Lupin Pharmaceuticals Inc. — clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 10, 2025

USA nationwide

What's affected?

Product: 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
Brand: CLOMIPRAMINE HYDROCHLORIDE
UPC: 0368180494065
Lot code: M300442

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2724 bottles.

View original FDA notice →

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