Drug product
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1054-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2600 100 ml bags/vials
- Official record key
drug-enforcement:D-1054-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: a) 58572:42 Use By: 05/29/2018 b) 58768:42 Use By: 06/20/2018;
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility