90%Confidence
0Views
FDASource
2026-03-16Date
Summary
AvKARE's recall of Amantadine due to failed dissolution specifications indicates a potential bioavailability issue, which could affect therapeutic efficacy. This may lead to temporary shortages and requires investigation into the manufacturing process.
Actionable: Evaluate supply chain for Amantadine HCl and monitor for competitor stock movements.
AI Confidence: 90%
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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