FarmaKeio recalls PT-141 (Bremelanotide Acetate) 10 mg/mL injections due to potential sterility issues. Products may not be sterile, risking infections. Check lot numbers on vials for affected items.
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 PT-141 injections because they may not be sterile, which could lead to infections. This affects patients using these medications under a prescription.
The product may not be sterile due to manufacturing issues, which could cause infections if injected. This is a serious risk for medical treatments.
Patients prescribed PT-141 injections by a doctor are affected. Those using the product without a prescription are not impacted.
Check for vials labeled 'PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection' from Farmakeio at 1736 N Greenville Ave, Richardson, TX. Look for lot numbers 32616 (BUD 4/4/2022) or 34527 (BUD 5/24/2022).
Look for lot numbers 32616 (BUD 4/4/2022) or 34527 (BUD 5/24/2022) on the vial label.
The product may not be sterile, which could cause infections. Do not use until the recall is resolved.
Check the lot number on the vial. If it matches 32616 or 34527, stop using it and contact Farmakeio.
The recall record does not specify a replacement process. Contact Farmakeio directly for assistance.
We’ve drafted a message you can send FarmaKeio to request your refund or repair — edit it as you like.
Subject: Recall D-0780-2022 — FarmaKeio FarmaKeio Hello, I own a FarmaKeio that is covered by recall D-0780-2022 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.
