PlainRecalls
FDA Drug Moderate Class II Completed

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Reported: July 28, 2021 Initiated: July 9, 2021 #D-0692-2021

Product Description

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
728 vials
Distribution
Nationwide within the United States
Location
Addison, TX

Frequently Asked Questions

What product was recalled?
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910. Recalled by Innoveix Pharmaceuticals Inc. Units affected: 728 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 28, 2021. Severity: Moderate. Recall number: D-0692-2021.