Drug product
SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
D-0613-2016
Product summary
- Event
- Event 72746
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags
- Official record key
drug-enforcement:D-0613-2016
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) 28-Sep-15, 1-Oct-15, b) 22-Sep-15, c) 30-Sep-15 d) 29-Sep-15, e) 25-Sep-15, f) 28-Sep-15
Distribution pattern: U.S. Including: VA, NC
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility