Drug Enforcement D-0537-2025

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

Status

Ongoing

Classification

Class II

Report Date

July 30, 2025

Termination Date

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Product Information

Product description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Product quantity
2,724 bottles
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
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-0537-2025
Event ID
97159
Recall initiation date
June 27, 2025
Center classification date
July 21, 2025
Code info
Lot # M300464, exp. date June, 2025
More code info
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