Drug product
METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
D-0125-2022
Product summary
- Event
- Event 88862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 324 vials
- Official record key
drug-enforcement:D-0125-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot: 07292021:79 BUD: 10/27/2021; 09072021:33 BUD: 12/07/2021; 09072021:32 BUD: 12/07/2021; 08312021:30 BUD: 11/29/2021; 07222021:66 BUD: 10/20/2021; 08242021:10 BUD: 11/22/2021; 07262021:12 BUD: 10/24/2021; 08182021:08 BUD: 11/16/2021; 09072021:31 BUD: 12/07/2021; 09092021:32 BUD: 12/08/2021; 09212021:12 BUD: 12/20/2021; 09212021:88 BUD: 12/20/2021.
Distribution pattern: United States including Washington, D.C. and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility