The Recall Desk
HighFDA (Drugs)·D-0310-2023·Announced 2023-02-22

Nafcillin Antibiotic Infusion Recalled Due to Sterility Assurance Failure

Sentara Infusion Services is recalling 16 bags of nafcillin antibiotic infusion nationwide due to lack of sterility assurance. Patients should contact their healthcare provider 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: FDA Class II recall of an injectable medication due to lack of sterility assurance. The source text explicitly reports no illnesses or hospitalizations, and the hazard is theoretical. However, injectable medication contamination presents serious potential for harm, justifying High severity.

Plain-English summary

Sentara Infusion Services is recalling nafcillin 24GM in normal saline 1200ML, an intravenous antibiotic medication. The recall affects 16 bags of this medication that were dispensed to patients nationwide.

The recall was initiated due to lack of sterility assurance. Nafcillin is an injectable antibiotic that must be sterile to be safe for patient use. If the sterility of the medication cannot be assured, there is a risk of microbial contamination that could cause serious infection.

Patients who received this medication should contact their healthcare provider or pharmacy immediately. The affected medication has a beyond-use date of December 25–31, 2022. Patients should not use any remaining supply of this medication without guidance from their healthcare provider.

The recalled product

Product
NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Hazard
  • lack-of-sterility
  • infection-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 25-31
  • 2022

Distribution

Distributed nationwide across the United States.