80%Confidence
0Views
FDASource
2026-03-10Date
Summary
AvKARE recalls Amantadine HCl capsules due to failed dissolution specifications, a Class II issue affecting drug efficacy. This may indicate manufacturing or stability problems, potentially leading to supply shortages and increased regulatory oversight.
Actionable: Monitor AvKARE's supply chain for disruptions and assess impact on patients reliant on this medication for Parkinson's or influenza.
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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