Assurance Infusion Recalls BUP/CLON/FENT Injection Due to Sterility Concerns
Assurance Infusion is recalling a specific lot of BUP 20MG/CLON 300MCG/FENT 2000MCG/ML Injection due to a lack of sterility assurance.
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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Assurance Infusion is recalling a specific lot of BUP 20MG/CLON 300MCG/FENT 2000MCG/ML Injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product is identified by Lot 12122019@28 with an expiration date of 12/21/2019. The recall is classified as Class II by the U.S. Food and Drug Administration.
The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- BUP 20MG/CLON 300MCG/FENT 2000MCG/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: 12122019@28 Exp. 12/21/2019
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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