Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility-failure
infection-risk
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 →

Same manufacturer · Assurance Infusion

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Same hazard · sterility failure