Drug product
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1529-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-1529-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 07012022@6, BUD: 09/20/2022; 07192022@16, BUD: 09/17/2022; 07012022@4, BUD: 08/30/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility