Class II · Moderate risk Ongoing
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville…
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
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
- 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-0779-2022
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 Melanotan recalls
See all
Class II · Moderate risk Terminated
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason Lack of sterility assurance.
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