Drug product
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1213-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2162 bags
- Official record key
drug-enforcement:D-1213-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EK051810 Exp. 5/4/2019; EK281808 Exp. 5/27/2019; EL101810 Exp. 6/8/2019; EL141807 Exp. 6/12/2019; EA081910 Exp. 7/7/2019; EA161908 Exp. 7/15/2019; EA301908 Exp. 7/29/2019; EB111907 Exp. 8/10/2019; EC041907 Exp. 8/31/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility