The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category