Assurance Infusion Recalls Quadmix Forte Injection Due to Sterility Concerns
Assurance Infusion is recalling 134 vials of Quadmix Forte injection nationwide because the product lacks sterility assurance.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported in the text, the lack of sterility assurance in an injectable drug is a significant safety hazard that aligns with the Severe classification for Class II recalls involving potential serious harm.
Plain-English summary
Assurance Infusion is recalling 134 vials of Quadmix Forte 30mg/4mg/40mcg/400mcg/mL Injection. The recall covers 1 mL vials distributed nationwide within the United States.
The recall was initiated due to a lack of sterility assurance for the product. The source text does not specify the exact nature of the sterility failure or report any specific illnesses or injuries associated with the use of these vials.
Patients who have received this medication should contact their healthcare provider for guidance. The recall includes specific lots with expiration dates ranging from December 2019 to April 2020.
The recalled product
- Product
- QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 134
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 (6)
- Lots: 07222019@10 Exp. 01/18/2020
- 06242019@19 Exp. 12/21/2019
- 08132019@15 Exp. 02/09/2020
- 10292019@22 Exp. 04/26/2020
- 11272019@24 Exp. 01/22/2020
- 09182019@18 Exp. 03/16/2020
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.
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