The Food and Drug Administration (FDA) is warning healthcare professionals and consumers that counterfeit versions of Cialis (tadalafil; Eli Lilly) 20mg tablets were discovered in the mail in transit to a United States consumer.

Cialis is FDA-approved for the treatment of erectile dysfunction (ED), treatment of benign prostatic hyperplasia (BPH), and treatment of ED and signs/symptoms of BPH. A laboratory analysis found the counterfeit versions to contain several active ingredients that could lead to adverse effects. Due to the products’ unknown source, the FDA cannot confirm the manufacturing, quality, storage or handling and thus has been deemed unsafe.

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The counterfeit versions can be identified by the following label characteristics:

  • Lists “AUSTR81137” on the front of the bottle
  • Does not include an NDC number on the front of the bottle
  • Does not include the tablet strength in a colored box
  • Has different patterns and colors; it has yellow and darker green designs on the front label
  • Has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle
  • Lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle
  • Lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle

The FDA is reminding that consumers should not use products that display any of the characteristics listed above. Consumers should only purchase prescription drugs from state-licensed pharmacies in the United States.

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