Class II · Moderate risk Ongoing
Sermorelin Lyophilized powder for reconstitution
Reason Lack of Assurance of Sterility
Ipamorelin Acetate/Sermorelin Acetate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
What was recalled
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
- Recalling firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0777-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sermorelin recalls
See all
Class II · Moderate risk Completed
Sermorelin Acetate 1 MG/ML Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Sermorelin Acetate 1 mg/mL
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Sermorelin Acetate
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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