Assurance Infusion Recalls Morphine Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Morphine 30mg/mL injection syringes due to a lack of sterility assurance. The affected products were 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 severity score under the rubric for significant injury risks or hospitalization potential associated with lack of sterility in injectable drugs.
Plain-English summary
Assurance Infusion is voluntarily recalling two syringes of Morphine 30mg/mL injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance in the manufacturing process.
The affected products include lots 12132019@6 (expiration date 12/22/2019) and 12182019@5 (expiration date 12/27/2019). These products were distributed nationwide within the United States.
Healthcare providers and patients should stop using the affected syringes and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2
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: 12132019@6 Exp. 12/22/2019
- 12182019@5 Exp. 12/27/2019
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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