Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The product 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 involving significant injury or property damage reports, or structural defects, are rated as Severe. Lack of sterility assurance in an injectable drug poses a significant risk of infection.
Plain-English summary
Assurance Infusion is recalling a specific lot of a multi-drug injection product. The product is a 20 mL syringe containing Baclofen, Buprenorphine, Clonazepam, Hydromorphone, and Sufentanil. The recall is being conducted because of a lack of sterility assurance.
The affected product is identified by Lot 12172019@3 with an expiration date of 12/26/2019. The distribution pattern for this recall is nationwide within the United States.
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
- BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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: 12172019@3 Exp. 12/26/2019
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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