Drug product
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1055-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 1-ml syringe
- Official record key
drug-enforcement:D-1055-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 58897:42 Use By: 07/04/2018
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility