Reported Nov 8, 2017 · Terminated

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC…

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?

    • Duloxetine Delayed-release Capsules USP
    • 20 mg
    • 50 Capsules (5 x 10) Unit Dose per carton
    • unit dose blister UPC 5026828311)
    • Rx only
  • Manufactured forAvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15
Lot codes and dates
  • Lot18103 Exp. 11/18
Amount recalled
274 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.

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 Mar 11, 2019 · Data as of Sep 19, 6:33 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.