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
Endo International plc (NASDAQ / TSX: ENDP) today announced that one of its
operating companies, 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.
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.
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 by following the instructions below:
Please contact Inmar at 1-844-529-1586, Monday through Friday (9am to 5pm
EST) or email Edex@inmar.com
for the following:
Upon contacting Inmar and indicating you have unused product, please expect
Return Authorization labels and Shipping instructions.
Upon contacting Inmar, please be prepared to share proof of purchase.
Proof of purchase can be sent to Edex@inmar.com
or 635 Vine St. Winston
Salem, NC 27101-Attention Recall Department, Edex Recall.
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 athttp://www.endo.com/endopharma/our-products
Inmar: Inmar Customer Service 877-208-2407