Agency classClass IIOur severity:High FDA (Drugs)·D-1528-2022·Announced 2022-09-21

TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance

Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.

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 classified as FDA Class II and involves lack of sterile assurance on an injectable medication, which presents significant risk of serious infection. No illnesses or injuries have been reported to date, placing it at High severity per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable, 10 mL vials, due to lack of assurance of sterility. The recall affects two specific lots distributed nationwide in the United States.

Non-sterile injectable medications pose a significant risk of infection to patients. If these products were administered and contaminated, patients could develop serious infections at injection sites or systemically.

The affected lots are: Lot 07052022@8 (expiration date 09/03/2022) and Lot 07292022@10 (expiration date 09/27/2022). Patients who have received injections from these lots should contact their healthcare provider immediately to report any signs of infection, including redness, warmth, swelling, or drainage at injection sites.

Healthcare providers should stop using these lots and properly dispose of any remaining product according to pharmaceutical waste protocols.

The recalled product

Product: TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable / Sterility
Hazard: sterility-failure
infection-risk
Affected units: 2

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 (4)

Lots: 07052022@8
BUD: 09/03/2022
07292022@10
BUD: 09/27/2022

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

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