FDA Recalls Pantoprazole Injectable Syringes for Sterility Assurance Failure
Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.
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 FDA Class II recall involves an injectable pharmaceutical with unverified sterility, which poses a risk of contamination and infection. No illnesses or hospitalizations have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling Pantoprazole 30mg in normal saline, 7.5ml syringe formulation. The recall affects 14 bags of this injectable medication.
The recall was issued due to lack of sterility assurance for the product. Pantoprazole is an injectable proton pump inhibitor used to treat certain stomach and esophageal conditions. When injectable medications lack verified sterility, they risk being contaminated, which could lead to serious infections in patients.
The affected product was dispensed to patients nationwide. Patients who have received this medication should contact their healthcare provider immediately if they experience signs of infection, fever, or other adverse effects following treatment.
Patients and healthcare providers with questions about this recall should contact Sentara Infusion Services for further information and guidance.
The recalled product
- Product
- PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Infusion
- Hazard
- lack-of-sterility
- infection-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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