FDAFDA · Food and drugs·Recall number D-0537-2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Published July 30, 2025 · Recall initiated: June 27, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide.
- UPC
- 0368180494065
- Lot
- Lot # M300464, exp. date June, 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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