The Recall Desk
SevereFDA (Drugs)·D-0764-2020·Announced 2020-01-22

Assurance Infusion Recalls Quadmix Injection Vials Due to Sterility Concerns

Assurance Infusion is recalling 190 vials of Quadmix injection nationwide due to a lack of sterility assurance. The recall covers nine specific lots distributed across the United States.

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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in an injectable drug, align with a Severe rating (Score 4) as it poses a significant risk of harm, though not explicitly Class I.

Plain-English summary

Assurance Infusion is recalling 190 vials of QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vials. The recall was initiated because of a lack of sterility assurance in the product. The affected product is distributed nationwide within the United States.

The recall covers nine specific lots with the following identifiers and expiration dates: 07012019@30 (Exp. 12/28/2019), 08052019@13 (Exp. 02/01/2020), 09252019@15 (Exp. 03/23/2020), 10292019@12 (Exp. 04/26/2020), 10092019@6 (Exp. 03/04/2020), 10162019@12 (Exp. 04/13/2020), 12042019@31 (Exp. 01/18/2020), 12162019@35 (Exp. 01/30/2020), and 11262019@37 (Exp. 05/24/2020).

Consumers and healthcare providers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to Assurance Infusion at (713) 533-8800.

The recalled product

Product
QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable Medication
Hazard
Affected units
190

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 (9)

  • Lots: 07012019@30 Exp. 12/28/2019
  • 08052019@13 Exp. 02/01/2020
  • 09252019@15 Exp. 03/23/2020
  • 10292019@12 Exp. 04/26/2020
  • 10092019@6 Exp. 03/04/2020
  • 10162019@12 Exp. 04/13/2020
  • 12042019@31 Exp. 01/18/2020
  • 12162019@35 Exp. 01/30/2020
  • 11262019@37 Exp. 05/24/2020

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

See all →

Same hazard · sterility failure

See all →