FDA-Drug2026-03-04Class II
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.
AvKARE
Hazard
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Sold states
Nationwide in the USA.
Affected count
N/A
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2026Original summary
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. Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. Lot # 49261, Exp: 04/30/27 Distribution: Nationwide in the USA. Affected quantity: N/A
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