Drug product
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1214-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6746 bags
- Official record key
drug-enforcement:D-1214-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EK021807, EK021807A Exp. 5/1/2019; EK261807 Exp. 5/25/2019; EK271808 Exp. 5/26/2019; EK301811 Exp. 5/29/2019; EL261811 Exp. 6/24/2019; EL281808 Exp. 6/26/2019; EA031908 Exp. 7/2/2019; EA111908 Exp. 7/10/2019; EA181907 Exp. 7/17/2019; EA281908 Exp. 7/27/2019; EB071908 Exp. 8/6/2019; EB201909 Exp. 8/19/2019; EC151907 Exp. 9/11/2019.
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility