Recall D-0986-2022
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
Recall D-0986-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0986-2022 |
Event ID | 90257 |
Distribution | Product was distributed to medical facilities and a physician's office Nationwide in the USA. |
Quantity | 781 vials |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220615 |
Recall Initiation Date | 20220524 |
Report Date | 20220615 |
Classification Date | 20220606 |
Address | 1401 S Albert St Allentown, PA 18103-4141 United States |
Recalling Firm | US Specialty Formulations LLC |
Initial Notification | Letter |
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