Agency classClass IIOur severity:High FDA (Drugs)·D-1527-2022·Announced 2022-09-21

TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance

Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.

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: FDA Class II recall with lack of sterility assurance on an injectable product. This is a risk-of-harm product where injury has not yet been reported. No illnesses or adverse events have been reported, placing this in the High category per the rubric.

Plain-English summary

Carolina Infusion LLC is recalling TRI-MIX 30/1/20 Injectable (5 mL vials), a prescription medication distributed nationwide in the United States.

The recall was issued due to lack of assurance of sterility. Injectable medications must meet strict sterility standards to prevent microbial contamination. The manufacturer cannot verify that this product meets these required standards.

The recall affects seven vials across multiple lots with beyond-use dates ranging from August 2022 to October 2022. Affected lots are: 06272022@6 (BUD 08/26/2022), 07212022@3 (BUD 09/19/2022), 07292022@11 (BUD 09/27/2022), 08052022@7 (BUD 10/04/2022), 08102022@5 (BUD 10/09/2022), 08122022@14 (BUD 10/11/2022), and 08172022@7 (BUD 10/16/2022).

Healthcare providers and patients who may have this product should contact their healthcare provider. No illnesses or adverse events have been reported in connection with this recall to date.

The recalled product

Product: TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
contamination-risk
infection-risk
Affected units: 7

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 (7)

Lots: 06272022@6 BUD: 08/26/2022
07212022@3 BUD: 09/19/2022
07292022@11 BUD: 09/27/2022
08052022@7 BUD: 10/04/2022
08102022@5 BUD: 10/09/2022
08122022@14 BUD: 10/11/2022
08172022@7 BUD: 10/16/2022

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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