Vancomycin Injectable Bags Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 155 bags of vancomycin injectable solution in multiple concentrations due to lack of sterility assurance. The product was dispensed nationwide for home infusion use.
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 involving lack of sterility assurance in an injectable antibiotic product intended for parenteral administration. While no illnesses or hospitalizations have been reported, the absence of sterility assurance in injectable medications poses a significant infection risk and qualifies as a high-risk product where potential injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling 155 bags of vancomycin injectable solution in seven different formulations, ranging from 500 mg to 2 gm, due to lack of sterility assurance associated with the product.
The recalled product was dispensed to patients nationwide for use with home infusion pumps. The product carries a beyond-use date of December 24–31, 2022.
Patients currently using this medication should contact their healthcare provider or pharmacy immediately. Do not use the recalled product without consulting with a healthcare professional.
The recalled product
- Product
- Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 3
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- 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 24-31
- 2022
Distribution
Distributed nationwide across the United States.
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