Morphine Sulfate Intravenous Solutions Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions (1 mg/mL and 5 mg/mL) distributed nationwide due to lack of sterility assurance. The products may not be sterile, creating a potential risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a parenteral medication with potential for serious infection if contaminated. No illnesses or injuries have been reported. The recall addresses a manufacturing quality defect (lack of sterility assurance) that creates risk of harm to patients.
Plain-English summary
Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions that were dispensed to patients nationwide. The products come in two concentrations: 1 mg/mL in 350 mL sodium chloride and 5 mg/mL in 200 mL sodium chloride. A total of 11 bags were prepared by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia, for use with Curlin infusion pumps. The affected products have a beyond-use date of December 24-31, 2022.
The recall was initiated due to lack of sterility assurance. Parenteral (injectable) medications must be sterile to prevent serious infections. The manufacturer determined that sterility requirements may not have been adequately assured during the preparation of these products.
Patients who received these products should contact their healthcare provider or pharmacy immediately. Do not use these products if you still have access to them.
The recalled product
- Product
- MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Parenteral
- Hazard
- lack-of-sterility
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)
- Beyond Use Date: December 24-31
- 2022
Distribution
Distributed nationwide across the United States.
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