FDAHealthJune 27, 2025
Lupin Pharmaceuticals Inc. — clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
⚠️ Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 27, 2025
Nationwide.
What's affected?
- Product
- clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
- UPC
- 0368180494065
- Lot code
- M300464
Additional details
Lot # M300464, exp. date June, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,724 bottles.
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