Recall: Edex for Erectile Dysfunction

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Endo Pharmaceuticals has issued a voluntary recall of Edex (alprostadil), an injection used to treat male erectile dysfunction.

This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled Edex, with the knowledge of the FDA.

Why was Edex recalled?

Endo Pharmaceuticals has voluntarily recalled one lot of Edex because of a defect in the crimp caps. This defect in the caps could lead to a loss of proper closure, compromising the sterility of the product. Improper sterility could lead to infection at the site of injection or in the blood stream.

However, at this time there have not been any adverse events reported to Endo Pharmaceuticals due to this recall.

Which products were recalled?

In this recall, only one lot was affected. The affected lot was distributed from December 13th, 2016 through February 13th, 2017 to wholesale distributers and retail pharmacies in the United States.

The recall only affects the 10 mcg 2-pack injection carton, lot #207386 (Exp 5/2019).

What should I do if I have the recalled Edex product?

If you have the recalled Edex product, immediately discontinue use of the product and contact Inmar at 1-844-529-1586 or Edex@inmar.com.

To find out more about the Edex recall, you can read the manufacturer’s press release here.

If you have concerns that your prescription may be affected, contact your doctor or pharmacist for more information.

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