Endo recalls self-injected male sexual dysfunction drug Edex

Endo Pharmaceuticals has had a string of recalls in the last few years.

Endo is having a hard time. The Dublin-based company, which Tuesday reported a $3.34 billion loss for the fourth quarter, is recalling one lot of an erectile dysfunction drug that is injected directly into the penis because of a problem with containers that could lead to infections.

According to a company release circulated in an FDA Safety Alert, its Endo Pharmaceuticals unit is recalling one lot of Edex because of a defect in the crimp caps. It said the problem could lead to contamination, which in turn could result in infections, not just localized but also systemically. So far, Endo said it has not received any reports of that happening.

The recall applies to the 10 mcg strength, which is packaged in a two-pack carton and was distributed to wholesalers and pharmacies throughout the U.S. from Dec. 13, 2016, through Feb. 13, 2017. It has a lot number of 207386.

The company has had a string of recalls in the last couple of years. In November, it recalled 162 lots, comprising 1,365,559 tablets, of its Gildess birth control pills because some of them may have been subpotent. Those were made by its Par unit, which the drugmaker acquired in 2015 in an $8 billion deal.

Endo, which has struggled since that deal, reported today that in the fourth quarter, its revenue rose 16% to $1.24 billion but its loss widened to $3.34 billion. Paul Campanelli, who was named CEO last September, said the company is making progress turning the situation around. Among other efforts, he said the company streamlined its global supply chain.

Suggested Articles

Hospital-backed Civica Rx has struck a deal for a CDMO to help it develop its own brand of drugs, for which it will own the rights.

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.