Skip to content
Recall Observatory FDA recall evidence

Drug product

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

D-1526-2022

August 26, 2022

Class II

Product summary

Firm
Carolina Infusion
Event
Event 90798
Status
Completed
Classification
Class II
Quantity
16 vials
Official record key
drug-enforcement:D-1526-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 06282022@1, BUD: 08/27/2022; 06292022@8, BUD: 08/28/2022; 07012022@19, BUD: 08/30/2022; 07012022@3, BUD: 08/30/2022; 07122022@8, BUD: 09/10/2022; 07132022@9, BUD: 09/11/2022; 07192022@1, BUD: 09/17/2022; 07292022@9, BUD: 09/27/2022; 08032022@10, BUD: 10/02/2022; 08092022@2, BUD: 10/08/2022; 08102022@1, 08102022@6, 08102022@7, BUD: 10/09/2022; 08152022@5, BUD: 10/14/2022; 08192022@1, 08192022@10, BUD: 10/18/2022

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility