Skip to Content

Caverject FDA Alerts

The FDA Alert(s) below may be specifically about Caverject or relate to a group or class of drugs which include Caverject (alprostadil).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for alprostadil

Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

Feb 27, 2017

Audience: Urology, Pharmacy, Patient

ISSUE: Endo Pharmaceuticals Inc. is recalling one lot of Edex (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot. This defect has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.

The recall applies to the 10 mcg strength, packaged in a 2 pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019. The affected lot was distributed from December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States. See the press release for product photos.

BACKGROUND: Edex (alprostadil for injection) is a prescription only intracavernous injection indicated for the treatment of male erectile dysfunction.

RECOMMENDATION: Consumers in possession of any unused prescribed Edex 10 mcg product bearing lot number 207386 should immediately discontinue use of the product and return the unused product. Please contact Inmar at 1-844-529-1586, Monday through Friday (9am to 5pm EST) or email Edex@inmar.com (refer to press release for further information).

Pharmacists and wholesalers are asked to check their inventories for lot number 207386, segregate any impacted inventory and contact Inmar at extension #1 at 1-800-967-5952, Monday through Friday (9 a.m. to 5 p.m. EST) or via e-mail at rxrecalls@inmar.com for instructions on product return. Pharmacists who have dispensed impacted product are asked to notify their patients of this recall. Pharmacies and wholesalers that received lot number 207386 will receive a letter as well as a copy of this press release with their recall notification information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/24/2017 - Press Release - FDA]

Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance

May 30, 2013

Audience: Consumer

 

[Posted 05/30/2013]

ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.

The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.

BACKGROUND: To date, Lowlite has received no reports of injury or illness associated with the use of the affected products.

RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Lowlite by phone at 888-323-7788 or 407-673-2222 from the hours of 9:00AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: Brian@olympiapharmacy.com. Patients who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[05/30/2013 - Press Release - Olympia Pharmacy]
[05/30/2013 - Recalled Product List - Olympia Pharmacy]

More Caverject Resources