80%Confidence
0Views
FDASource
2026-04-15Date
Summary
Amneal's tramadol tablets failing stability testing for nitrosamine impurities indicates potential shelf-life and quality assurance problems. This could affect market confidence in Amneal's manufacturing capabilities and lead to batch recalls.
Actionable: Assess exposure to Amneal's generic tramadol supply chain and consider alternative sources.
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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