Endo Recalls Erectile Dysfunction Medication Due to Sterility Concerns

Endo Pharmaceuticals has voluntarily recalled 1 lot of its Edex (alprostadil for injection) 10 mcg due to lack of sterility assurance, according to an FDA press release. Edex is a prescription only intracavernous injection indicated to treat male erectile dysfunction.

The recalled product was found to contain a defect in the crimp caps used in the manufacture of the subject product lot, which could lead to a loss of container closure integrity. The defect has the potential to cause serious adverse events such as infections, both localized at the site of injection and systemically. The product should be immediately discontinued and returned.

The recall applies to the 10-mcg strength, packaged in a 2-pack carton, product lot number 208386, expiration date: May 2019. The affected lot was distributed from December 13, 2016 through February 13, 2017 through wholesale distributors and pharmacies. No adverse events related to this recall have been reported.

The FDA urges pharmacists and wholesalers to check their inventories for the recalled lot number, segregate impacted inventory, and notify patients who have been dispensed the recalled product.

Reference

Endo Pharmaceuticals Inc. issues voluntary nationwide recall for one lot of Edex (alprostadil for injection) 10 mcg 2 pack carton due to potential lack of sterility assurance [news release]. Gaithersburg, MD. FDA’s website. https://www.fda.gov/Safety/Recalls/ucm543470.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Feb. 27, 2017.