80%Confidence
0Views
FDASource
2026-04-16Date
Summary
Amneal's tramadol tablets failing impurities specifications at 24-month stability testing reveals potential long-term quality issues in their manufacturing process. This could affect product shelf life and regulatory compliance for controlled substances.
Actionable: Assess Amneal's broader product portfolio for similar stability issues and potential regulatory actions.
AI Confidence: 80%
Data Points
firmAmneal Pharmaceuticals, LLC
classificationClass II
statusOngoing
distributionNationwide within the USA
producttraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, D
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