The Recall Desk
HighFDA (Drugs)·D-1532-2022·Announced 2022-09-21

TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance

Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable medication with a sterility assurance failure. The source text does not report any illnesses, injuries, or hospitalizations. However, injectable medications with unassured sterility pose a significant risk-of-harm, fitting the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Carolina Infusion LLC is recalling TRI-MIX 50/2.5/25 Injectable, 2 ML vials, Rx only. The recalled lot is 07052022@2 with a Beyond Use Date of 09/03/2022. This product was distributed nationwide in the United States.

The recall is due to a lack of assurance of sterility. Injectable medications must be sterile; when sterility cannot be assured, the product poses a potential safety risk.

If you have received this medication from the affected lot, do not use it. Contact your healthcare provider or pharmacy for guidance on this recall.

The recalled product

Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer
Carolina Infusion
Category
Drug — Injectable
Hazard
  • sterility-failure
  • microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 07052022@2
  • BUD: 09/03/2022

Distribution

Distributed nationwide across the United States.

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