Drug product
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1215-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3007 bags
- Official record key
drug-enforcement:D-1215-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EK131812 Exp. 5/12/2019; EL051809 Exp. 6/3/2019; EL111808 Exp. 6/9/2019; EL141808 Exp. 6/12/2019; EA031909 Exp. 7/2/2019; EA141909 Exp. 7/13/2019; EA311910 Exp. 7/30/2019; EB061909 Exp. 8/5/2019; EC121909 Exp. 9/8/2019; EC251910 Exp. 9/21/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility