FDA recalls unregistered erectile dysfunction drug

MANILA, Philippines - The Food and Drug Administration (FDA) has ordered the recall of Cialis (generic name tadalafil) 20-milligram tablet, a drug for erectile dysfunction that was found to be unregistered.

Based on an investigation conducted by the FDA, the product was found to be marketed by Eli Lilly Phils., Inc. “without a renewed valid Certificate of Product Registration (CPR), hence unregistered.”

“The safety, efficacy, and quality of the product need to be established again for it to be granted an authorization in the form of a CPR,” the FDA said.

The agency noted that Eli Lilly Phils., Inc., the licensed importer, has committed to recall the product. 

The FDA warned doctors against prescribing Cialis and consumers against buying and using the product.

“All FDA inspectors are hereby directed to ensure that no tadalafil (Cialis) product can be found in Eli Lilly’s distributor’s warehouses and in retail drugstores,” the FDA added.

Eli Lilly assured the public yesterday that the recall of Cialis “is not related to safety, efficacy or quality.”

In a statement, Eli Lilly said the product “will temporarily be out of the shelves in the Philippines until its license is renewed” by the FDA.

It added that the product “remains one of the best-selling impotency drugs in the world (while) in the Philippines, it is one of the most prescribed drugs by doctors since 2005.”