Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
FDA recall notice · announced July 28, 2021 · Innoveix Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
Quantity: 728 vials
Status: Completed
Products in this recall event:
- Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 (D-0693-2021)
- Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 (D-0692-2021)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.