Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 1

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.

Part of a larger recall action

This product is one of 20 recalled by Carolina Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Carolina Infusion

See all →

High
Injectable drug product recalled for lack of sterility assurance
FDA (Drugs) · 2022-09-21
High
Injectable Steroid Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
High
Injectable testosterone product recalled for sterility assurance defect
FDA (Drugs) · 2022-09-21
High
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
High
Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21

Same hazard · sterility failure