Cefoxitin injectable bags recalled nationwide for sterility assurance failure
Cefoxitin injectable antibiotic (1GM and 2GM) prepared by Sentara Infusion Services is being recalled nationwide due to lack of sterility assurance. Affected patients should contact their pharmacy immediately.
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 addresses lack of sterility assurance in an injectable medication—a significant hazard for injectables. The source reports no illnesses, injuries, or hospitalizations, placing it in the high-risk category as a risk-of-harm product without reported adverse outcomes.
Plain-English summary
Sentara Infusion Services is recalling CEFOXITIN injectable bags in two strengths: 1 gram in 50 milliliters of normal saline and 2 grams in 100 milliliters of normal saline. These sterile injectable medications are designed for use with home infusion pumps. The affected products have a beyond-use date of December 30, 2022.
The recall was initiated due to lack of sterility assurance. Cefoxitin is an antibiotic used to treat bacterial infections. Sterility is critical for injectable medications; any contamination could result in serious infections or complications in patients.
The affected products have been dispensed to patients nationwide. Patients who have received or may have received this medication should contact their pharmacy or healthcare provider immediately to determine whether they have received any recalled product and to discuss alternative treatment options.
The recalled product
- Product
- CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Antibiotic
- Hazard
- sterility-failure
- injection-contamination
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 30
- 2022
Distribution
Distributed nationwide across the United States.
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