Metronidazole injectable antibiotic recalled due to sterility concerns
Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg injectable antibiotic distributed nationwide due to lack of sterility assurance. Patients using the product should contact their healthcare provider.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in intravenous medication—qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg 100ml injectable antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide, with a beyond-use date of December 24-29, 2022.
Metronidazole is an antibiotic administered via intravenous infusion, for use with or without a home pump. The lack of sterility assurance indicates that the product may not meet required sterility standards and could potentially expose patients to contamination risks.
Patients who received this product should contact their healthcare provider to discuss the recall and any potential concerns related to their use of the medication.
The recalled product
- Product
- METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Intravenous Antibiotic
- Affected units
- 30
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 24-29
- 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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