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
D-0986-2022
Product summary
- Event
- Event 90257
- Status
- Terminated
- Classification
- Class II
- Quantity
- 781 vials
- Official record key
drug-enforcement:D-0986-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23
Distribution pattern: Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility