Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Drug: Ipamorelin
- Recalling firm
- Innoveix Pharmaceuticals Inc
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0692-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ipamorelin recalls
See all
Class II · Moderate risk
Sermorelin Acetate 9mg/Ipamorelin 9mg - Lyophilized 9mg/9mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Sermorelin Acetate 6mg/Ipamorelin 6mg - Lyophilized 6mg/6mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Sermorelin Acetate 15mg/Ipamorelin 15mg - Lyophilized 15mg/15mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Cjc-1295 4mg/Ipamorelin 4mg Vial 4mg/4mg Injectable
Lack of assurance of sterility
Other recalls by Innoveix Pharmaceuticals Inc
All 2021 recalls
Class II · Moderate risk
Compounded Lyophilized AOD-9604
Lack of Assurance of Sterility
Class II · Moderate risk
Lyophilized Human Chorionic Gonadotropin 5
Lack of Sterility Assurance.
Class II · Moderate risk
Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Lack of Sterility Assurance.
Class II · Moderate risk
Lyophilized Human Chorionic Gonadotropin 5
Lack of Sterility Assurance.
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