FDAFDA · Food and drugs·Recall number D-0986-2022
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
Published June 15, 2022 · Recall initiated: May 24, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Specialty Formulations LLC
- Distributor
- Product was distributed to medical facilities and a physician's office Nationwide in the USA.
- Lot
- Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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