Drug recall D-0377-2025
Product
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
Reason for recall
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.
Lots and codes
Lot #: M300442, Exp Date: 6/30/2025
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Naples, FL
- Quantity
- 2724 bottles
- Distribution
- USA nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 10, 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.