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Recall Observatory FDA recall evidence

Drug product

TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

D-1530-2022

August 26, 2022

Class II

Product summary

Firm
Carolina Infusion
Event
Event 90798
Status
Completed
Classification
Class II
Quantity
11 vials
Official record key
drug-enforcement:D-1530-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 07052022@10, BUD: 09/03/2022; 07052022@16, BUD: 09/03/2022; 07122022@11, BUD: 09/08/2022; 07182022@17, BUD: 09/16/2022; 07202022@6, BUD: 09/18/2022; 07252022@9, BUD: 09/23/2022; 0729202222@2, BUD: 09/27/2022; 07292022@13, BUD: 09/27/2022; 08122022@9, BUD: 10/11/2022; 08162022@2, BUD: 10/15/2022; 082620222@1, BUD: 10/25/2022

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility