Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Recall Number: D-0341-2026
Firm: AvKARE
Classification: Class II
Status: Ongoing
Report Date: 20260304
Initiation Date: 20260213
Termination Date:
Reason for Recall
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Product Description
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.