FDA finds more counterfeit Cialis, warns consumers

Counterfeit Cialis--Courtesy of FDA

Earlier this month the FDA stopped a shipment of what it believed to be Cialis manufactured in Australia that it said contained improper ingredients. Cialis maker Eli Lilly ($LLY), however, said the product appeared to be counterfeit. It made no Cialis in Australia. Now the FDA is saying it has found Cialis fakes being shipped in the mail and is warning consumers to beware.

While the shipments were stopped, the FDA said in a warning posted to its website it is concerned more of the product may have gotten through. So far it is unaware of any adverse events but said analysis found the counterfeit versions contain multiple active ingredients, "which if used could result in adverse effects or harm." It warned consumers to only buy prescription medicines from U.S. pharmacies.

The warning said the product packaging has some differences which can tip off the careful reader to the fact it is fake, including misspellings that say, "CLALIS is a product of: Eli lilly Australia PTY Limited." The packaging lists the manufacturer location as "112 Wharf Road, WEST RYDE, NSW 2114," on the side of the bottle.

Two weeks ago the FDA posted an import alert, banning what it said was Eli Lilly's Cialis made at a plant in West Ryde, Australia because testing showed it contained not only tadalafil, the active pharmaceutical ingredient approved for Cialis, but also sildenafil, the API that goes in Pfizer's ($PFE) competing erectile dysfunction drug Viagra.

Lilly responded that the drugs had to be fake. The company said it quit manufacturing human drugs in Australia in 1985 and its animal health operation stopped making products there in 2008. "Lilly has never manufactured Cialis in Australia," Lilly spokeswoman Celeste Stanley explained. "This appears to be a counterfeit version of Cialis." The company pointed out that erectile dysfunction drugs are often counterfeited, citing statistics that 37% of seized counterfeits are ED drugs.

- here's the FDA warning

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