Assurance Infusion Recalls Fentanyl Syringes Due to Sterility Concerns
Assurance Infusion is recalling Fentanyl 3000mcg/mL injection syringes due to a lack of sterility assurance. The affected lots were 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 no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk of serious harm, aligning with the Severe criteria for Class II recalls with potential for significant injury.
Plain-English summary
Assurance Infusion is voluntarily recalling Fentanyl 3000mcg/mL injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product includes two specific lots: 12122019@18 with an expiration date of 12/21/2019, and 12162019@24 with an expiration date of 12/25/2019. The product was distributed nationwide within the United States.
Healthcare providers and consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. For further information, contact Assurance Infusion at (713) 533-8800.
The recalled product
- Product
- FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 2
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 (2)
- Lots: 12122019@18 Exp. 12/21/2019
- 12162019@24 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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