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.
Ipamorelin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drug: Ipamorelin
- Recalling firm
- Advanced Nutriceuticals, LLC
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0134-2021 · 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.
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 Advanced Nutriceuticals, LLC
All 2020 recalls
Class II · Moderate risk
Pentosan Polysulfate
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Ll-37
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
High Dose B12
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Ghk-Cu
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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