FDA-Drug2022-06-15Class II

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

US Specialty Formulations LLC
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Affected count
781 vials
Manufactured in
1401 S Albert St, Allentown, PA, United States
Products
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

Official notice

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

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