Drug product
Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
D-0634-2016
Product summary
- Event
- Event 72746
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 Bags
- Official record key
drug-enforcement:D-0634-2016
Official wording
Reason: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Code information: All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-15
Distribution pattern: U.S. Including: VA, NC
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility