FDA recall D-0986-2022

US Specialty Formulations LLC · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed to medical facilities and a physician's office Nationwide in the USA.

Key facts

Status
Terminated
Initiation date
2022-05-24
Report date
2022-06-15
Termination date
2024-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0986-2022