Fake Cialis Found in Mail to U.S. Customers

The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015.

The agency said tests on samples of a counterfeit 20 mg version of Eli Lilly’s Cialis (tadalafil) also contained sildenafil, the active ingredient in Pfizer’s Viagra. The suspected drug was found during a normal screening of a mail shipment at a U.S. port. The FDA couldn’t say how many bottles were in the shipment, but did confirm the counterfeit drugs did not reach any consumers, spokesman Stephen King said.

The FDA incorrectly attributed Eli Lilly as the manufacturer of the suspected product and placed the company on import alert, King said. A plant in Australia was listed as the producer of the suspected drugs, but Lilly told the FDA that it doesn’t produce any products in the country and doesn’t have a facility there.

FDA realized its error and took Lilly’s name off the import alert.

While the label includes references to Australia, the package was actually mailed from China, according to King.

“Because we know this product is counterfeit, we do not know where it was actually made,” he said. “Unscrupulous players or criminals often take such steps to make it difficult to be identified or linked to the counterfeit product.”

King said the agency is working with manufacturers, distributors and pharmacies to identify and prevent any additional counterfeit products from reaching consumers. The fake Cialis can be spotted by its label, which misspells the drug’s name. The spurious versions are labeled Clalis. The label on also lacks the tablet strength in a colored box and says the drug was manufactured in Australia.

The FDA is not aware of any adverse events connected to counterfeit Cialis. Erectile dysfunction drugs are among the most commonly faked pharmaceuticals.

Lilly has spent $110 million to implement new technology to serialize and electronically trace its products through unique codes and serial numbers on each drug package, said spokeswoman Celeste Stanley. The Drug Quality and Security Act mandates serialization for all drug products by November 2018.

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