Drug product
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1052-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4900 100-ml vials
- Official record key
drug-enforcement:D-1052-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 58495:42 Use By: 05/22/2018; 58703/58733 Use By: 06/10/2018; 58852:42 Use By: 06/22/2018; 59006:42 Use By: 07/10/2018;
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility