Endo Recalls Erectile Dysfunction Injection

Endo Pharmaceuticals Inc. voluntarily recalls one lot of Edex due to potential lack of sterility assurance.

Endo's Edex Injection / Image: edguidance.com
Endo's Edex Injection / Image: edguidance.com

On Monday, February 27th the FDA announced the Endo Pharmaceutical’s voluntary nationwide recall of Edex, a prescription only intracavernous injection used in the treatment of male erectile dysfunction. Lot 207386 is believed to contain a defect in the crimp caps used in the manufacture, which could lead to a loss of container closure integrity and sterility.

The recall only applies to the 10 mcg strength version, which is packaged in a two-pack carton. The affected lot was distributed throughout the U.S. between Decmeber and February. Consumers in possession of products from the affected lot should discontinue use and return any unused product.

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Sustainable Healthcare Packaging Solutions That Work
Industry leaders share proven strategies for reducing packaging emissions by up to 70% while meeting safety and regulatory requirements.
Read More
Sustainable Healthcare Packaging Solutions That Work