Drug product
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1053-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5000 500-ml bags
- Official record key
drug-enforcement:D-1053-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility