The Recall Desk
HighFDA (Drugs)·D-0282-2023·Announced 2023-02-22

Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling Ceftriaxone antibiotic infusions nationwide because the manufacturer cannot assure the products meet sterility standards. Patients 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 of injectable medications with lack of sterility assurance. No illnesses or hospitalizations have been reported, but the inability to ensure sterility of injectable antibiotics poses a significant infection risk.

Plain-English summary

Sentara Infusion Services is recalling Ceftriaxone (available in formulations of 1 gram in 50 milliliters saline, 4 grams in 200 milliliters saline, and 8 grams in 400 milliliters saline) distributed nationwide. The recall is due to lack of sterility assurance, meaning the manufacturer cannot confirm that the products are free from microbial contamination.

This recall affects all patients who received these Ceftriaxone products with a beyond-use date of December 25-30, 2022. The products were dispensed nationwide through Sentara Home Infusion Pharmacy Services located in Chesapeake, Virginia.

Patients who have received these medications should contact their healthcare provider or pharmacist immediately to discuss whether they received affected products. Do not use remaining supplies without consulting a healthcare professional. Healthcare providers should verify patient exposure and monitor accordingly.

The recalled product

Product
CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home 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 25-30
  • 2022

Distribution

Distributed nationwide across the United States.