Reported Apr 30, 2025 · Terminated
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 5801 Pelican Bay Blvd · Naples, FL · 34108-2755
Is this the product you have?
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only
- Manufactured ForLupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States
- Manufactured ByLupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
- Lot codes and dates
- Lot #: M300442
- Exp Date6/30/2025
- Amount recalled
- 2724 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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