80%Confidence
0Views
FDASource
2026-04-17Date
Summary
Amneal Pharmaceuticals' stability failure for tramadol tablets due to nitrosamine impurities indicates potential long-term quality control issues at their Indian manufacturing facility. This could affect product shelf life and market availability, impacting both Amneal and its distributors.
Actionable: Evaluate alternative tramadol suppliers and review inventory of affected Amneal products for potential quality concerns.
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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