Vital Care Compounder recalls vancomycin intravitreal 1mg/0.1ml solution in 0.5ml syringes (lots 65432, 66347, 66864) due to 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 has recalled vancomycin intravitreal solution in 0.5ml syringes because the FDA found the manufacturing process could not ensure the products were sterile. This poses a risk of infection if used improperly.
The FDA inspection found the production process did not guarantee the products were sterile. If the solution is not sterile, it could cause serious infections in the eye after injection.
Patients prescribed this medication by a doctor for eye infections. Those using the product without medical supervision are at risk of infection.
Check for syringes labeled 'VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only'. Lot numbers 65432 (BUD: 10/13/2022), 66347 (BUD: 11/05/2022), or 66864 (BUD: 11/18/2022).
Look for lot numbers 65432, 66347, or 66864 on the syringe packaging.
The FDA found the manufacturing process did not guarantee the products were sterile.
No, the product may not be sterile and could cause eye infections if used.
Check the lot number on the syringe packaging. If it matches the recalled lots, contact your doctor or pharmacy.
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-0056-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0056-2023 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.
