Agency classClass IIOur severity:High FDA (Drugs)·D-1529-2022·Announced 2022-09-21

Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance

Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.

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 FDA Class II recall involves an injectable medication with lack of sterility assurance. No illnesses or injuries have been reported in the source text. The hazard represents a risk of serious harm (infection, sepsis) from potential contamination, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carolina Infusion LLC is recalling TRI-MIX 30/1/60 Injectable, 5 ML vials, nationwide due to lack of assurance of sterility. Three specific lots are affected, with Beyond Use Dates of August 30, 2022; September 17, 2022; and September 20, 2022. The product was distributed across the United States.

Injectable medications must maintain strict sterility standards to prevent serious infections. The lack of assured sterility means this product cannot be guaranteed to be free from contamination.

If you have received this medication, contact your healthcare provider immediately. Do not use any vials from the recalled lots. Healthcare providers and patients should follow appropriate clinical guidance regarding potential exposure.

The recalled product

Product: TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable / Sterile Injectable
Hazard: lack-of-sterility
contamination
Affected units: 3

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 (6)

Lots: 07012022@6
BUD: 09/20/2022
07192022@16
BUD: 09/17/2022
07012022@4
BUD: 08/30/2022

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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