Cefepime injectable antibiotic bags recalled due to sterility concerns
Sentara Infusion Services is recalling 71 bags of Cefepime injectable antibiotic due to lack of sterility assurance. Patients who received affected doses should consult 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 for injectable medication with sterility concerns. No illnesses or hospitalizations reported in the source; the hazard is theoretical, placing this at High severity per the rubric.
Plain-English summary
Sentara Infusion Services is recalling 71 bags of Cefepime antibiotic medication in varying concentrations (2 gram, 8 gram, and 12 gram preparations in saline solution). The recall affects medication dispensed nationwide to patients with a beyond-use date of December 24-31, 2022, which was designed for use with Curlin or Home infusion pumps.
The recall was issued because these doses were found to lack adequate sterility assurance. Cefepime is an intravenous antibiotic administered to patients for serious bacterial infections. Contamination of injectable medications poses a serious health risk.
The affected doses were dispensed directly to patients nationwide through Sentara Home Infusion Pharmacy Services. Patients who received Cefepime with a beyond-use date between December 24 and December 31, 2022 may have received affected product.
Patients who received affected doses should contact their healthcare provider or infusion pharmacy immediately to discuss their treatment. Do not use any remaining doses from affected bags. Seek medical attention if you experience signs of infection, fever, or other concerning symptoms after receiving treatment.
The recalled product
- Product
- CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Hazard
- lack-of-sterility
- 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 24-31
- 2022
Distribution
Distributed nationwide across the United States.
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