FDA-Drug2025-04-30Class II
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
Lupin Pharmaceuticals Inc.
Hazard
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.
Sold states
USA nationwide
Affected count
2724 bottles
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0377-2025Don't want to check this manually?
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