Endo Pharmaceuticals Inc., based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex (alprostadil) for injection because the company detected a defect in the crimp caps used in the manufacture of the subject product lot.
“This defect has the potential to lead to a loss of container closure integrity, which could impact the product's sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically,” Endo wrote in its press release. “To date, [the company] has not received adverse event reports related to this recall.”
Edex, a prescription-only intracavernous injection, treats male erectile dysfunction. The recall specifically relates to the 10 mcg strength, packaged in a two-pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019. According to the company, this product was distributed to wholesale distributors as well as retail pharmacies in the United States between Dec. 13, 2016 and Feb. 13, 2017.
Endo noted that the U.S. Food and Drug Administration is aware of the recall.