Edex (alprostadil for injection) is a prescription-only intracavernous injection indicated for the treatment of male erectile dysfunction, and to help diagnose certain causes of this disorder. It is also used to improve blood flow in newborn babies with a certain genetic heart condition.
Endo Pharmaceuticals Inc is recalling one lot of Edex (alprostadil for injection) 10 mcg. Endo Pharmaceuticals detected a defect in the crimp caps used in the manufacture of the recalled lot – which applies to the 10mcg strength, packed in a 2-pack carton (NDC 52244-010-02, product lot no. 207386, with an expiration date of May 2019). The affected lot was distributed from the 13th of December 2016 through to the 13th of February 2017 to wholesale distributors and retail pharmacies throughout the United States.
The 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 localised at the site of injection and systemically.
What do you have to do next?
Endo Pharmaceuticals Inc advises its customers in possession of any unused prescribed Edex 10 mcg product bearing lot number 207386 should immediately stop using and return any unused product. So check your medicine cabinets to make sure you don’t have this particular lot in possession. Customers affected can call Inmar at +1-844-529-1586 between 9am and 5pm (EST) Monday to Friday, or e-mail [email protected] for instructions on the return process.
Pharmacists who have dispensed impacted product are asked to notify their patients of this recall. All Pharmacists and wholesalers should check their inventories for lot number 207386, segregate any impacted inventory, and call Inmar at +1-844-529-1586, or e-mail [email protected] for instructions on returning the product. Pharmacies and wholesalers that received lot number 207386 will receive a letter as well as a copy of the press release from the FDA with their recall notification information.
The FDA is encouraging all health care professionals and patients to report any adverse events or side effects related to the use of the Comprehensive Reverse Shoulder to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-332-1088.
Read the full FDA alert here.