Nalbuphine Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
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: FDA Class II recall of injectable medication with lack of sterility assurance. No illnesses or injuries have been reported, making this a risk-of-harm situation without confirmed harm, fitting the High severity category.
Plain-English summary
Sentara Infusion Services is recalling 31 nalbuphine injectable syringes that were dispensed to patients nationwide. The recalled products are nalbuphine 1.5mg in 1.5mL normal saline and nalbuphine 2.5mg in 2.5mL normal saline, both in syringe form. These are prescription-only opioid pain medications.
The recall is due to lack of sterility assurance, meaning the manufacturing and compounding processes may not have maintained adequate control to ensure the product remained sterile. This could potentially expose patients to contaminated medication.
All 31 syringes with a beyond-use date of December 29, 2022 are affected. The syringes were dispensed directly to patients by Sentara Home Infusion Pharmacy Services, based in Chesapeake, Virginia.
Patients who received these syringes should contact their healthcare provider or Sentara Infusion Services immediately. Do not use the recalled syringes. Healthcare providers should identify affected patients and provide alternative pain management.
The recalled product
- Product
- NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Hazard
- lack-of-sterility-assurance
- contamination-risk
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 29
- 2022
Distribution
Distributed nationwide across the United States.
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