Bogus Versions of Eli Lilly's Cialis Found Entering the U.S. By Mail, Says FDA

January 22, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) has alerted the public that counterfeit versions of the erectile dysfunction drug Cialis were found in the mail on its way to a consumer. The shipment was stopped. FDA lab analysis showed the counterfeit drug contained “multiple active ingredients, which if used could result in adverse effects or harm”, the FDA said in a statement.

The FDA is concerned that other shipments could exist and has posted pictures of the counterfeit package as compared to the authentic package of Cialis on the agency’s website. The counterfeit bottle includes “AUSTR81137” on the front and does not have an NDC number or the tablet strength in a colored box. The pattern is different than that of the authentic Cialis; it has yellow and a darker green design on the label. In addition, the following misspellings appear on the side of the bottle, “CLALIS is a product of: Eli Lilly Australia PTY Limited.”

Further identifying features include the location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle and “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle. Though an address is listed, the FDA stated the counterfeit Cialis is from an “unknown source.”

The FDA stated it was not aware of any “consumer adverse events” due to the use of the counterfeit Cialis, however, the agency recommends people speak to their health care professionals if they have received a counterfeit product. People are asked to report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.

Eli Lilly and Company makes the authentic Cialis and, according to the FDA, there is no indication its supply chain is at risk. People “can be confident” that the prescription medication they purchase from state-licensed pharmacies in the U.S. is “safe and effective.”

“Lily does not manufacture Cialis in Australia,” said Eli Lilly spokeswoman Celeste Stanley in a statement earlier this month. “In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine.”

Stanley further stated that Lilly stopped manufacturing human drugs in Australia in 1985. "Lilly has never manufactured Cialis in Australia," she said.

Pharmaceuticals are among the top five counterfeit products seized in the U.S., according to a March 2014 article in USA Today.

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