Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2025-07-30
Distribution
Nationwide.
Firm state
FL
Product quantity
2,724 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Product description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Code / lot info
Lot # M300464, exp. date June, 2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.