Assurance Infusion Recalls BUP 3 mg/MORP 15 mg/mL Injection Syringes
Assurance Infusion is recalling BUP 3 mg/MORP 15 mg/mL Injection syringes due to a lack of sterility assurance. The recall covers specific lots 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 and involves a lack of sterility assurance in an injectable drug, which poses a risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Assurance Infusion is recalling BUP 3 mg/MORP 15 mg/mL Injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product is identified by the following lot numbers and expiration dates: Lot 12162019@28 (Exp. 12/25/2019) and Lot 12102019@1 (Exp. 12/19/2019). The product was distributed 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
- BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- 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 (2)
- Lots: 12162019@28 Exp. 12/25/2019
- 12102019@1 Exp. 12/19/2019
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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