FarmaKeio recalls 10mL Melanotan II injections due to potential sterility issues. Products may cause infections if used without proper sterility.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
FarmaKeio is recalling specific Melanotan II injections because they may not be sterile, which could lead to infections. This affects people using these injections for medical purposes.
The injections may not be sterile due to manufacturing issues. This could lead to infections if the product is used without proper sterility checks.
People with prescriptions for Melanotan II injections from Farmakeio are affected. Those using the product for medical purposes face the highest risk.
Check for vials labeled 'Melanotan II 1 mg/mL (10 mL) Injection' with lot numbers 32610 (BUD 4/4/2022) or 35126 (BUD 6/7/2022).
Look for lot numbers 32610 (BUD 4/4/2022) or 35126 (BUD 6/7/2022) on the vial.
The recall states there is a risk of not being sterile, which could cause infections. Do not use these products.
Check for vials labeled 'Melanotan II 1 mg/mL (10 mL) Injection' with lot numbers 32610 (BUD 4/4/2022) or 35126 (BUD 6/7/2022).
The recall does not specify a remedy, so contact Farmakeio for guidance.
We’ve drafted a message you can send FarmaKeio to request your refund or repair — edit it as you like.
Subject: Recall D-0779-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0779-2022 from FarmaKeio. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
