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Wed Apr 30 2025
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.
Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
---|---|---|---|
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 | Lupin Pharmaceuticals, Inc. | USA nationwide | 2724 bottles |
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