Endo Pharmaceuticals Issues Voluntary Nationwide Recall for One Lot of Edex®

Endo International has announced that one of its operating companies, Endo Pharmaceuticals Inc. based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex® (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of 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. To date, Endo has not received adverse event reports related to this recall.

Edex® (alprostadil for injection) is a prescription only intracavernous injection indicated for the treatment of male erectile dysfunction. The recall applies to the 10 mcg strength, packaged in a 2 pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019 (see photographs of packaged product within). The affected lot was distributed from December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States. The lot number can be found on the manufacturer's unit. Consumers who are unsure if they have the affected lot number should consult their pharmacist or health care professional.