Vancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue
Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk intravenous antibiotic product due to lack of sterility assurance. The source contains no report of confirmed contamination, illness, or adverse events. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High.
Plain-English summary
Sentara Infusion Services is recalling Vancomycin antibiotic intravenous solution in two formulations: 700 mg in 140 mL normal saline and 1000 mg in 200 mL normal saline. The recall affects 18 bags that were dispensed to patients nationwide.
The recall was initiated because the product lacks adequate sterility assurance. This is a Class II recall issued by the U.S. Food and Drug Administration.
Patients or healthcare providers who have received this medication should contact Sentara Infusion Services or consult their healthcare provider for guidance on next steps.
The recalled product
- Product
- VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Intravenous Antibiotic
- Affected units
- 18
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 28-31
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services 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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