FarmaKeio recalls ARA-290 (Cibinetide Acetate) 6 mg/mL injections due to potential sterility issues. This affects specific lot numbers sold in Texas. Patients should contact their doctor for guidance.
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 a specific type of prescription injection because it may not be sterile. This could lead to infections if used improperly. Patients with this medication should consult their doctor immediately.
The product may not be sterile due to manufacturing process deviations. This could cause infections if the injection is used, as sterile medical products are critical for safe treatment.
Patients prescribed this injection for medical use. Those with the specific lot numbers mentioned in the recall are most at risk.
Check the product label for the lot numbers 32618 (BUD 4/4/2022) or 34525 (BUD 5/24/2022). This injection is only available by prescription and sold through Farmakeio in Richardson, Texas.
Since the remedy is not specified in the recall, patients should talk to their healthcare provider for guidance on next steps.
The recall states there is a risk of not being sterile, which could cause infections. Patients should not use it without consulting their doctor.
Lot numbers 32618 (BUD 4/4/2022) and 34525 (BUD 5/24/2022) are affected.
This product was sold through Farmakeio at 1736 N Greenville Ave, Richardson, TX 75081.
We’ve drafted a message you can send FarmaKeio to request your refund or repair — edit it as you like.
Subject: Recall D-0775-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0775-2022 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.
