Drug Enforcement D-0377-2025

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.

Status

Ongoing

Classification

Class II

Report Date

April 30, 2025

Termination Date

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Product Information

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
Product quantity
2724 bottles
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
5801 Pelican Bay Blvd, Suite 500

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0377-2025
Event ID
96681
Recall initiation date
April 10, 2025
Center classification date
April 18, 2025
Code info
Lot #: M300442, Exp Date: 6/30/2025
More code info
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