Reported Jun 21, 2023 · Ongoing

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478,…

Avkare LLC

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 LLC · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only
  • Manufactured for
    • AvKARE Pulaski
    • TN 38478
    • NDC 50268-772-13
Lot codes and dates
  • Lot44286 Exp. 02/2025
Amount recalled
592 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

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

Data as of Sep 19, 7:17 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.