Drug product
Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1060-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 100-ml vials
- Official record key
drug-enforcement:D-1060-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 58212:42 Use By: 06/01/2018
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility