Assurance Infusion Recalls Buprenorphine and Fentanyl Injection Due to Sterility Concerns
Assurance Infusion is recalling a specific lot of buprenorphine and fentanyl injection due to a lack of sterility assurance. The product 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 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. While the source does not explicitly state hospitalization reports, the 'lack of sterility assurance' in an injectable drug presents a significant risk of serious injury (infection/sepsis), aligning with the Severe criteria for significant injury reports or high-risk defects.
Plain-English summary
Assurance Infusion is recalling a specific lot of BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot 12162019@29 with an expiration date of 12/25/2019.
The recall is classified as FDA Class II. The product was distributed nationwide within the United States. No specific number of affected units or reported illnesses is provided in the source text.
Consumers and healthcare providers should stop using the affected product and contact Assurance Infusion at (713) 533-8800 for further instructions or a refund.
The recalled product
- Product
- BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- 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: 12162019@29 Exp. 12/25/2019
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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