88%Confidence
0Views
FDASource
2026-03-15Date
Summary
AvKARE recalls Amantadine HCl capsules due to failed dissolution specifications, indicating potential bioavailability issues. This Class II recall may affect treatment efficacy for patients and could lead to increased regulatory oversight for the manufacturer.
Actionable: Review AvKARE's quality control processes for dissolution testing and consider alternative sources for Amantadine HCl if needed.
AI Confidence: 88%
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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