FDAFDA · Food and drugs·Recall number D-0377-2025
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
Published April 30, 2025 · Recall initiated: April 10, 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 18-month long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- USA nationwide
- UPC
- 0368180494065
- Lot
- Lot #: M300442, Exp Date: 6/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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