Endo Pharmaceuticals has recalled one lot of Edex (alprostadil for injection) 10mcg to the consumer level, due to lack of sterility assurance
This product recall is due to the detection by the company 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 localised at the site of injection and systemically.
To date, Endo has not received adverse event reports related to this recall.
Edex is a prescription only intracavernous injection indicated for the treatment of male erectile dysfunction. The recall applies to the 10mcg strength, packaged in a two pack carton.
Endo states that it takes this issue seriously and is fully committed to ensuring all of its products and packaging meet the highest quality standards.
This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).