Vital Care Compounder recalls sterile PAPAVERINE/PHENTOLAMINE injection vials due to lack of sterility assurance. Products may cause infections if used. Check lot numbers on vials for affected batches.
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 sterile PAPAVERINE/PHENTOLAMINE injection vials because FDA found they weren't produced with enough sterility assurance. Using these vials could lead to infections if they're not properly sterilized.
The FDA found that the manufacturing process for these vials did not guarantee sterility. This means the products could contain harmful bacteria or other contaminants that might cause infections when injected.
Prescription users of this injectable medication who received vials with lot numbers 55092, 59100, 62038, or 66533. Healthcare providers and patients using these products are at risk of infection.
Check the lot number on the vial (55092, 59100, 62038, or 66533) and the expiration date (BUD) on the packaging. These vials are sold as prescription-only products.
Look for lot numbers 55092, 59100, 62038, or 66533 on the vial packaging.
If you have the recalled vials, contact your healthcare provider for guidance on next steps.
Using these vials could lead to infections due to potential contamination from the manufacturing process.
Check the lot number on the vial packaging; affected lots are 55092, 59100, 62038, or 66533.
The recall does not require immediate discontinuation but requires checking lot numbers and consulting your healthcare provider.
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-0046-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0046-2023 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.
