Drug product
Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
D-0614-2016
Product summary
- Event
- Event 72746
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags
- Official record key
drug-enforcement:D-0614-2016
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) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15
Distribution pattern: U.S. Including: VA, NC
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility