Assurance Infusion Recalls QUADMIX Vials Due to Sterility Concerns
Assurance Infusion is recalling QUADMIX in 1 mL vials because of a lack of sterility assurance. The affected lot was distributed nationwide.
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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly when involving sterility assurance issues which carry significant health risks.
Plain-English summary
Assurance Infusion is recalling QUADMIX in 1 mL vials due to a lack of sterility assurance. The recall involves 5 vials from Lot 07012019@30, which has an expiration date of 12/28/2019.
The product was distributed nationwide within the United States. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact Assurance Infusion at (713)-533-8800 for further instructions.
The recalled product
- Product
- QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Infusion
- Hazard
- Affected units
- 5
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 (1)
- Lot: 07012019@30 Exp. 12/28/2019
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.
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