The cap defect can potentially result in compromised container closure integrity, which affects the drug’s sterility assurance. This can lead to serious adverse events such as localized and systemic infections.
Edex, a prostaglandin, is an intracavernous injection indicated to treat male erectile dysfunction. The recalled product was supplied in 2-count cartons with Lot #207386 and an expiration date of May 2019. The affected lot was distributed to wholesale distributors and retail pharmacies between December 13, 2016 through February 13, 2017.
Pharmacists who possess the impacted product are requested to contact their patients regarding this recall. Consumers who possess any unused prescribed Edex 10mcg with the recalled Lot # should immediately stop use of the product and arrange for return.
Endo has not received any reports of adverse events related to this recall so far. Edex is also available in 20mcg and 40mcg strengths.
For more information call (800) 462-3636 or visit Endo.com.