US Specialty Formulations recalls ethanol injection vials with potential lack of sterility. Affected lots expire by September 2022 to June 2023. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
US Specialty Formulations is recalling ethanol injection vials that may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates up to June 2023.
The ethanol injection vials may not be sterile, which can cause infections if used in medical procedures. This is a risk for patients receiving injections under medical supervision.
Prescription users of ethanol injection vials for medical purposes. Patients using the recalled lots are at risk of infection if the product is not sterile.
Check for the product name 'Ethanol for Injection 95%, 67 mL Multi-Dose vial' with lot numbers 02RP1503A (expires Sep 2022), 02RP1506A (expires Dec 2022), or 02RP1516A (expires Jun 2023).
Look for lot numbers 02RP1503A, 02RP1506A, or 02RP1516A on the vial label.
The vials may not be sterile, which could lead to infections if used in medical procedures.
Check for lot numbers 02RP1503A (expires Sep 2022), 02RP1506A (expires Dec 2022), or 02RP1516A (expires Jun 2023).
The recall does not specify a remedy, so contact US Specialty Formulations for further instructions.
We’ve drafted a message you can send US Specialty Formulations to request your refund or repair — edit it as you like.
Subject: Recall D-0986-2022 — US Specialty Formulations US Specialty Formulations Hello, I own a US Specialty Formulations that is covered by recall D-0986-2022 from US Specialty Formulations. 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.
