The Recall Desk
SevereFDA (Drugs)·D-0776-2020·Announced 2020-01-22

Assurance Infusion Recalls Trimix Forte Injection Due to Sterility Concerns

Assurance Infusion is recalling 358 vials of Trimix Forte injection nationwide due to a lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

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 significant risk of serious injury or infection.

Plain-English summary

Assurance Infusion is recalling 358 vials of Trimix Forte 30mg/2mg/20mcg/mL Injection. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product is distributed nationwide within the United States. The recall covers specific lots with expiration dates ranging from December 2019 to April 2020.

Consumers and healthcare providers should stop using the affected vials and contact Assurance Infusion at (713) 533-8800 for further instructions.

The recalled product

Product
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
358

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 (16)

  • Lots: 08082019@7 Exp. 02/04/2020
  • 08232019@1 Exp. 02/19/2020
  • 07262019@12 Exp. 01/22/2020
  • 07012019@25 Exp. 12/28/2019
  • 07102019@14 Exp. 01/06/2020
  • 09202019@4 Exp. 03/18/2020
  • 10282019@23 Exp. 04/25/2020
  • 10092019@7 Exp. 03/04/2020
  • 08292019@11 Exp. 02/25/2020
  • 10042019@6 Exp. 04/01/2020
  • 10162019@20 Exp. 04/13/2020
  • 11062019@24 Exp. 03/04/2020
  • 12042019@20 Exp. 01/18/2020
  • 12102019@11 Exp. 01/24/2020
  • 12162019@36 Exp. 01/30/2020
  • 11262019@29 Exp. 01/10/2020

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 →

Related recalls

Same manufacturer · Assurance Infusion

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Same hazard · lack of sterility

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