Assurance Infusion Recalls Buprenorphine and Morphine Injection Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Buprenorphine and Morphine 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable drug.
Plain-English summary
Assurance Infusion is recalling specific lots of BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe. The recall is being conducted due to a lack of sterility assurance in the product.
The affected product is identified by the lot number 12162019@6 with an expiration date of 12/25/2019. The recall covers distribution 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 or a return.
The recalled product
- Product
- BUP 5MG/MORP 20MG/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)
- Lots: 12162019@6 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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