Pharmacy Plus, Inc. dba Vital Care Compounder recalls PAPAVERINE HCL Stock Solution 30mg/ml 10mL vials due to lack of sterility assurance. FDA inspection found products not meeting sterile standards.
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 Compounder is recalling PAPAVERINE HCL stock solution vials because FDA found they were not produced with sterility assurance. This means the solution could be contaminated, posing a risk of infection if used in medical procedures.
FDA inspections found the products were produced without sufficient sterility assurance. This means the solution could contain harmful bacteria or other contaminants that could cause infections if used in medical procedures.
Healthcare professionals who use this medication for prescription purposes. Patients receiving this medication through a healthcare provider are at risk if the solution is contaminated.
Check for the product name 'PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial', Rx only, with lot number 60552 and batch date 03/12/2023.
Look for the lot number 60552 and batch date 03/12/2023 on the vial label.
No, the FDA found the products were not produced with sterility assurance, so they could be contaminated.
Check for the lot number 60552 and batch date 03/12/2023 on the vial label.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Vital Care Compounder to request your refund or repair — edit it as you like.
Subject: Recall D-0047-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0047-2023 from Vital Care Compounder. 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.
