Reported Apr 25, 2018 · Terminated

Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN…

AVKARE Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only
  • Manufactured forAvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Lot codes and dates
  • Lot16719 Exp. 07/2018
Amount recalled
2135 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 4, 2020 · Data as of Sep 19, 7:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.