Assurance Infusion Recalls Morphine Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Morphine 20mg/mL injection syringes nationwide 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. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in an injectable drug corresponds to a severity score of 4 (Severe).
Plain-English summary
Assurance Infusion is recalling three syringes of Morphine 20mg/mL Injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed nationwide within the United States. The specific lots involved are 12102019@7 (Exp. 12/19/2019), 12112019@11 (Exp. 12/20/2019), and 12162019@5 (Exp. 12/25/2019).
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
- MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 3
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 (3)
- Lot: 12102019@7 Exp. 12/19/2019
- 12112019@11 Exp. 12/20/2019
- 12162019@5 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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