Drug product
DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
D-0622-2016
Product summary
- Event
- Event 72746
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 7 Bags, b) 4 Bags
- Official record key
drug-enforcement:D-0622-2016
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: a) 30-Sep-15, b) 25-Sep-15
Distribution pattern: U.S. Including: VA, NC
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility