Drug product
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1517-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-1517-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 05042022@4 BUD: 10/31/2022; 062920222@9 BUD: 12/26/2022; 07262022@3 BUD: 01/22/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility