Vital Care Compounder recalls 10mL vial solutions of PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG for lack of sterility assurance. FDA inspection found production did not guarantee sterile products.
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 10mL vials of a prescription injectable drug due to a risk that the product may not be sterile. This could lead to infections if used improperly.
FDA inspections found the manufacturing process did not ensure the product was sterile. If the product is not sterile, it could cause infections when injected into the body.
Prescription drug users who received this specific vial solution from Vital Care Compounder. Patients using the product for medical purposes are most at risk.
Check for vials labeled 'PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG' with lot number 65594 and batch date 10/16/2022.
Look for the lot number 65594 and batch date 10/16/2022 on the vial label.
The FDA found the product was not produced with sterility assurance, so it may cause infections if used. Do not use this product.
Check for vials labeled 'PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG' with lot number 65594 and batch date 10/16/2022.
The recall does not specify a remedy, so contact your healthcare provider 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-0048-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0048-2023 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.
