Endo Pharmaceuticals is recalling one lot of the prescription injectable erectile dysfunction drug Edex (alprostadil) to the consumer level due to a defect in the crimp caps that has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility and lead to serious infections both at the injection site and systemically. To date, no repots of adverse events have been reported.
The recall affects the 10 mcg strength of Edex (alprostadil for injection), packaged in a two-pack carton with the NDC 52244-010-02, the product lot number 207386, and the expiration date of May 2019. The affected lot was distributed from Dec. 13, 2016, through Feb. 13, 2017, to wholesale distributors and retail pharmacies throughout the U.S. The lot number can be found on the manufacturer’s unit. Consumers who are unsure if they have the affected lot number should consult their pharmacist or health care professional.
Consumers who have affected doses of Edex in their possession should immediately discontinue use and return the unused portions by calling Inmar at 844-529-1586, email firstname.lastname@example.org for return instructions. The company will reimburse consumers for any unused products. Pharmacists and wholesalers have also been notified and asked to check their inventories for Edex affected by this recall, and been instructed to separate the drug from their inventory.
Any adverse events or side effects related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recalls