The Recall Desk
HighFDA (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.

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 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

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.

Related recalls

Same category