On February 27, 2017, the FDA issued a warning that Endo Pharma Company withdraws one batch of Edex (Alprostadil) drug from the US market.
The reason for Edex withdrawal is a manufacturing defect in the primary packaging, due to which there is no 100% guarantee of the sterility of this drug for the erectile dysfunction treatment.
The lack of a guaranteed sterility increases the risk of serious adverse reactions from the intracavernous administration of Edex, including systemic and localized infections.
- Edex batch registered under no. 207386 is withdrawn from the wholesale and retail US market (photo).
- This batch of the injecting drug Edex was supplied to the US pharmacies between 13.12.2016 and 13.02.2017.
Men who bought Edex (Alprostadil) in the above period should immediately stop using this injecting drug and return unused Edex doses to the seller.
Pharmacists, who received Edex batch under no. 207386 should stop the retail sales of this drug.The North American pharmaceutical distributors can get instructions for returning Edex (Alprostadil) by phone: 1-800-967-5952.