Drug product
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
D-1071-2018
Product summary
- Event
- Event 80118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2000 100-ml vials
- Official record key
drug-enforcement:D-1071-2018
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018
Distribution pattern: Texas
Derived failure modes
-
Sterility assurance
Lack of sterility