The Recall Desk
HighFDA (Drugs)·D-0306-2023·Announced 2023-02-22

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.

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 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
Hazard
  • lack-of-sterility
  • 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 24-29
  • 2022

Distribution

Distributed nationwide across the United States.