80%Confidence
0Views
FDASource
2026-03-14Date
Summary
AvKARE recalls Amantadine HCl capsules due to failed dissolution specifications, indicating potential reduced efficacy for this antiviral/parkinson's drug. This OOS finding could lead to supply shortages and increased scrutiny on AvKARE's quality control systems.
Actionable: Check inventory for affected Amantadine HCl lots and source alternatives to ensure patient access to treatment.
AI Confidence: 80%
Data Points
firmAvKARE
classificationClass II
statusOngoing
distributionNationwide in the USA.
productAmantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268
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