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March 2, 2017 FDA News

Endo Pharmaceuticals Recalls Self-Injected Erectile Dysfunction Drug Due to Concerns Over Sterility

On Friday, February 24th, FDA issued a press release stating that Endo Pharmaceuticals Inc. is recalling one lot of Edex® (alprostadil for injection) 10 mcg.

What is Edex?

Edex is a prescription only injection, self-injected for the treatment of erectile dysfunction in men.  Edex is manufactured by Endo Pharmaceuticals Inc., which is a subsidiary of Endo International plc.

Voluntary Nationwide Recall

Last week, Endo issued a voluntary nationwide recall of one lot of Edex.  The recall came after the company detected a defect in the crimp caps that are used in the manufacture of the subject product lot.  According to FDA’s press release, “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.”

At this point, Endo has not received any adverse event reports related to the recall.

“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 December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States.”

Returning Recalled Products

FDA states that any “consumers in possession of any unused prescribed Edex 10 mcg product bearing lot number 207386 should immediately discontinue use of the product and return the unused product. Please contact Inmar at 1-844-529-1586, Monday through Friday (9am to 5pm EST) or email Edex@inmar.com.”

In addition, the Agency is asking pharmacists and wholesalers to check their inventories for the appropriate lot number, segregate any impacted inventory, and contact Inmar (at extension #1 at 1-800-967-5952, Monday through Friday (9 a.m. to 5 p.m. EST) or via e-mail at rxrecalls@inmar.com) for instructions on how to return the product(s).  Furthermore, any “pharmacists who have dispensed impacted product are asked to notify their patients of this recall. Pharmacies and wholesalers that received lot number 207386 will receive a letter as well as a copy of this press release with their recall notification information.”

Reporting Adverse Events

The Agency encourages healthcare professionals and patients to report adverse events or side effects that are experienced related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

For additional information, view the full press release.

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