The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0773-2020·Announced 2020-01-22

Assurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns

Assurance Infusion is recalling 1,290 vials of TRIMIX injection nationwide due to a lack of sterility assurance. No specific illnesses or injuries are reported in the source text.

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: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a risk of harm (infection) even though no injuries are currently reported in the source text.

Plain-English summary

Assurance Infusion is voluntarily recalling 1,290 vials of TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product was distributed nationwide within the United States. The source text lists numerous specific lot numbers and expiration dates ranging from December 2019 to April 2020.

The source text does not report any specific illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should check their inventory for the listed lot numbers and contact the recalling firm for further instructions.

The recalled product

Product
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
1,290

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: 07082019@29 Exp. 01/04/2020
  • 06252019@11 Exp. 12/22/2019
  • 07082019@29 Exp. 01/04/2020
  • 06252019@6 Exp. 12/22/2019
  • 07082019@28 Exp. 01/04/2020
  • 07262019@3 Exp. 01/22/2020
  • 07102019@13 Exp. 01/06/2020
  • 07162019@13 Exp. 01/12/2020
  • 07242019@15 Exp. 01/20/2020
  • 07162019@12 Exp. 01/12/2020
  • 08272019@11 Exp. 02/23/2020
  • 08162019@6 Exp. 02/12/2020
  • 07312019@14 Exp. 01/27/2020
  • 07262019@4 Exp. 01/22/2020
  • 08152019@9 Exp. 02/11/2020
  • 08092019@6 Exp. 02/05/2020
  • 07312019@15 Exp. 01/27/2020
  • 08092019@5 Exp. 02/05/2020
  • 08272019@12 Exp. 02/23/2020
  • 09032019@36 Exp. 03/01/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 118 recalled by Assurance 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 118 products in this recall →

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