Endo Pharmaceuticals recalls one lot of Edex

Recall due to potential lack of sterility assurance.

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. The affected lot was distributed from 13 December 2016 through 13 February 2017 to wholesale distributors and retail pharmacies throughout the US. 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.