Reported Aug 23, 2017 · Terminated

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN…

AVKARE Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only
  • Manufactured forAvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Lot codes and dates
    • Lot #: 16933
    • Exp 07/2018
    • 17054
    • Exp 08/2018
Amount recalled
1172 cartons (23440 tablets)

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/degradation specifications: Out of specification for a related compound C.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 11, 2019 · Data as of Sep 19, 7:18 PM UTC

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