Assurance Infusion Recalls BUP 35MG/MORP 10MG/ML Injection Syringes
Assurance Infusion is recalling BUP 35MG/MORP 10MG/ML Injection syringes 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 and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Assurance Infusion is recalling BUP 35MG/MORP 10MG/ML Injection in 20 mL syringes. The recall was initiated because of a lack of sterility assurance. The affected product is identified by Lot 12162019@18 with an expiration date of 12/25/2019.
The recall covers one syringe per unit. The product was distributed nationwide within the United States. The FDA has classified this recall as Class II.
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 35MG/MORP 10MG/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 (1)
- Lot: 12162019@18 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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