Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

Recall Number: D-0986-2022

Firm: US Specialty Formulations LLC

Classification: Class II

Status: Terminated

Report Date: 20220615

Initiation Date: 20220524

Termination Date: 20240617

Reason for Recall

Lack of Assurance of Sterility

Product Description

Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229