Endo Pharmaceuticals Inc. Recalls One Lot of Edex® 10 mcg 2 Pack Carton

PUBLISHED: Feb 27, 2017

Endo Pharmaceuticals Inc. based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex® (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo 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 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 (see photographs of packaged product within). The affected lot was distributed from December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States. 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.

Pharmacists and wholesalers are asked to check their inventories for lot number 207386, 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 product return. 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.

Endo takes this issue seriously and is fully committed to ensuring all of its products and packaging meet the highest quality standards. If you have any questions regarding this recall, please call 1-800-462-ENDO (3636), between the hours of 8:00 a.m. to 8:00 p.m. EST Monday through Thursday and 8:00 a.m. to 6:00 p.m. EST on Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Additional information regarding this recall can be found at the link below.

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