Assurance Infusion Recalls Bi-Mix Forte Injections Due to Sterility Concerns
Assurance Infusion is recalling Bi-Mix Forte 30 mg/2 mg/mL injections because of a lack of sterility assurance. The affected lot was distributed nationwide.
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 with potential for serious injury (such as lack of sterility assurance in injectable drugs) are categorized as Severe.
Plain-English summary
Assurance Infusion is recalling Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials. The recall is due to a lack of sterility assurance. The specific lot affected is 07302019@15, with an expiration date of 01/29/2020.
The product was distributed nationwide within the United States. The recall is classified as Class II by the U.S. Food and Drug Administration.
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
- Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- 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: 07302019@15 Exp. 01/29/2020
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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