Vital Care recalls sterile injection vials of PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ due to lack of sterility assurance. FDA inspection found production couldn't guarantee sterile products. Affected vials have specific lot numbers and expiration dates.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Vital Care is recalling sterile injection vials containing PAPAVERINE, PHENTOLAMINE, and PROSTAGLANDIN. These products were made in a way that doesn't ensure they're sterile, which could lead to infections if used.
FDA inspections found the manufacturing process couldn't guarantee the products were sterile. This means the vials might contain harmful bacteria or other contaminants that could cause infections if injected.
Prescription patients using the recalled vials for medical treatment. Healthcare providers who dispensed these vials are also affected.
Check for vials labeled 'PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML' from Vital Care Compounder. Lot numbers 66450 (BUD: 11/07/2022) or 66527 (BUD: 11/09/2022) are affected.
Look for the specific product name and lot numbers listed in the recall notice.
FDA inspections found the manufacturing process couldn't guarantee the products were sterile, which could lead to infections if used.
The recall notice doesn't specify a remedy, so check with your healthcare provider or pharmacy for guidance.
Yes, lot numbers 66450 (BUD: 11/07/2022) and 66527 (BUD: 11/09/2022) are affected.
We’ve drafted a message you can send Vital Care to request your refund or repair — edit it as you like.
Subject: Recall D-0045-2023 — Vital Care Vital Care Hello, I own a Vital Care that is covered by recall D-0045-2023 from Vital Care. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
