D-0986-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- May 24, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 781 vials
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Code Information
Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23