Drug recall D-0537-2025
Product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
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.
Lots and codes
Lot # M300464, exp. date June, 2025
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Naples, FL
- Quantity
- 2,724 bottles
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 27, 2025
- Terminated
- January 5, 2026
Related products
- Clomipramine Hydrochloride – drug information
- NDC 68180-494 Clomipramine Hydrochloride · Clomipramine Hydrochloride 75 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-492 Clomipramine Hydrochloride · Clomipramine Hydrochloride 25 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-493 Clomipramine Hydrochloride · Clomipramine Hydrochloride 50 mg/1 · Lupin Pharmaceuticals, Inc.