Agency classClass IIOur severity:High FDA (Drugs)·D-1526-2022·Announced 2022-09-21

Injectable Drug Recall: TRI-MIX 30/1/10 Vials Lack Sterility Assurance

Carolina Infusion is recalling TRI-MIX 30/1/10 injectable vials nationwide because the sterility of the product cannot be assured. This FDA Class II recall affects 16 vials distributed across multiple lots with expiration dates through October 2022.

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 of an injectable product with compromised sterility assurance, which poses significant risk of serious infection if administered. No illnesses have been reported, making this a precautionary recall based on manufacturing/quality assurance failure rather than known harm.

Plain-English summary

Carolina Infusion LLC is recalling TRI-MIX 30/1/10 Injectable (10 mL vials) nationwide due to lack of assurance of sterility. The recall affects 16 vials distributed in multiple lots with manufacturing dates between June 2 and August 19, 2022.

Injectable medications must maintain strict sterility to prevent serious infections. This is an FDA Class II recall, indicating a quality assurance failure with potential for serious harm if sterile conditions were compromised. The manufacturer cannot verify that the recalled vials meet sterility standards.

Patients and healthcare providers with access to affected vials should discontinue use immediately and contact their healthcare provider for guidance. The FDA maintains a complete list of affected lot numbers and expiration dates (ranging from August 27, 2022, to October 18, 2022) on its website.

The recalled product

Product: TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable
Hazard: sterility
injectable
Affected units: 16

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 (20)

Lots: 06282022@1
BUD: 08/27/2022
06292022@8
BUD: 08/28/2022
07012022@19
BUD: 08/30/2022
07012022@3
07122022@8
BUD: 09/10/2022
07132022@9
BUD: 09/11/2022
07192022@1
BUD: 09/17/2022
07292022@9
BUD: 09/27/2022
08032022@10
BUD: 10/02/2022
08092022@2
BUD: 10/08/2022
08102022@1

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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