Drug product
Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
D-0616-2016
Product summary
- Event
- Event 72746
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags
- Official record key
drug-enforcement:D-0616-2016
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) 1-Oct-15, b) 29-Sep-15, c) 25-Sep-15, 30-Sep-15, d) 25-Sep-15, e) 1-Oct-15, f) 29-Sep-15, g) 26-Sep-15, h) 1-Oct-15, i) 29-Sep-15, j) 25-Sep-15, k) 1-Oct-15, l) 25-Sep-15, m) 27-Sep-15, 1-Oct-15, n) 24-Sep-15, 30-Sep-15, o) 25-Sep-15
Distribution pattern: U.S. Including: VA, NC
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility