FarmaKeio recalls Sermorelin Acetate 1 mg/mL injections due to potential sterility issues. Affected lots from 4/12/2022 to 6/7/2022. Stop using if you have these vials.
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 Sermorelin Acetate 1 mg/mL injections because they may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with production dates from April 2022 through June 2022.
The product may not be sterile due to deviations in manufacturing practices. If the injection is not sterile, it could cause infections when injected into the body.
People who have received Sermorelin Acetate 1 mg/mL injections from Farmakeio. Those with the specific lots listed in the recall are most at risk.
Check the lot number on the vial: 32963 (BUD 4/12/2022), 34824 (BUD 5/30/2022), or 35130 (BUD 6/7/2022). The product is sold by Farmakeio in Richardson, Texas.
Look for lot numbers 32963, 34824, or 35130 on the vial label.
The recall states there is a risk of not being sterile, which could cause infections. The official notice does not confirm if the product is safe to use.
Check the lot number on the vial: 32963 (BUD 4/12/2022), 34824 (BUD 5/30/2022), or 35130 (BUD 6/7/2022).
The recall does not specify a remedy, so the official notice does not say what to do next.
We’ve drafted a message you can send FarmaKeio to request your refund or repair — edit it as you like.
Subject: Recall D-0781-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0781-2022 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.
