FarmaKeio recalls LL-37 2 mg/mL (5 mL) injections due to potential sterility issues. Products may not be sterile, risking infections. Affected lots from April 2022.
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 LL-37 2 mg/mL injections because they might not be sterile. This could lead to infections if used improperly. The recall affects specific lots manufactured in April 2022.
The product may not be sterile due to manufacturing process deviations. This could cause infections if the injection is used without proper sterility checks.
Prescription users of LL-37 injections from Farmakeio in Richardson, TX. Patients who received these injections after April 2022 are most at risk.
Check for the lot number 33444 on the vial label. Products were sold by Farmakeio at 1736 N Greenville Ave, Richardson, TX starting April 2022.
Look for the lot number 33444 on the vial label to confirm if it's affected.
The recall states there is a lack of assurance of sterility, so it may not be safe to use.
Check the vial label for lot number 33444, which was produced starting April 2022.
The recall does not specify a remedy, so contact Farmakeio directly 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-0778-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0778-2022 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.
