FarmaKeio recalls 10mL vials of Ipamorelin/Sermorelin 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 10 mL vials of Ipamorelin/Sermorelin injections that may not be sterile. This could lead to infections if used without proper sterility checks.
The product may not be sterile due to manufacturing deviations. This could lead to infections if the injections are used without proper sterility checks.
Prescription users of these injections for medical treatments. Patients with compromised immune systems are at higher risk.
Check for 10 mL vials labeled 'Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection'. Products were sold with lot number 32961 and batch date 5/12/2022.
Look for the product name and lot number 32961 on the vial.
The product may not be sterile, so it could cause infections. Do not use without checking with your healthcare provider.
Check for 10 mL vials labeled 'Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection' with lot number 32961.
Contact your healthcare provider for guidance on whether to stop using the product.
We’ve drafted a message you can send FarmaKeio to request your refund or repair — edit it as you like.
Subject: Recall D-0777-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0777-2022 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.
