Drug product
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1516-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-1516-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 08012022@4 BUD: 01/28/2023; 08082022@12 BUD: 02/04/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility