Endo Pharmaceuticals Recalls Alprostadil

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The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

Endo International plc announced on Feb. 24, 2017 that Endo Pharmaceuticals (Malvern, PA) was voluntarily recalling one lot of Edex (alprostadil for injection) 10 mcg because of a defect in the crimp caps used to manufacture the recalled lot. The defect could lead to loss of container closure integrity, impacting the sterility of the product.

The recalled lot, which was distributed from Dec. 13, 2016–Feb. 13, 2017, is 10 mcg strength, packaged in a two-pack carton, (NDC 52244-010-02), product lot number 207386, and an expiration date of May 2019. Although the company has not to this date received any reports of adverse events, it is recommending that consumers discontinue use of the product. Adverse events can be reported to FDA via the agency’s website.

Edex (alprostadil for injection) is prescribed as a intracavernous injection for the treatment of male erectile dysfunction. A lack of sterility could lead to serious infections, both localized at the site of injection and systemically. 


Source: FDA