Drug product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1527-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 7 vials
- Official record key
drug-enforcement:D-1527-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 06272022@6 BUD: 08/26/2022; 07212022@3 BUD: 09/19/2022; 07292022@11 BUD: 09/27/2022; 08052022@7 BUD: 10/04/2022; 08102022@5 BUD: 10/09/2022; 08122022@14 BUD: 10/11/2022; 08172022@7 BUD: 10/16/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility