Reported Apr 17, 2019 · Terminated

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478…

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?

  • Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only
  • Manufactured forAvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Lot codes and dates
  • Lots
    • 201916 Exp. 08/2019
    • 20092 Exp. 08/2019
Amount recalled
397 bottles

Where it was sold

Why it was recalled

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

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 May 7, 2020 · Data as of Sep 19, 7:49 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.