The Recall Desk
HighFDA (Drugs)·D-0297-2023·Announced 2023-02-22

Antibiotic Injectable Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling an antibiotic injectable medication due to lack of sterility assurance. Seven bags were dispensed to patients nationwide with a Beyond Use Date of December 2022.

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 is an FDA Class II recall of an injectable antibiotic where sterility is essential to patient safety. No illnesses or injuries are reported in the source document, placing this in the 'risk-of-harm product where injury has not yet been reported' category per the severity rubric.

Plain-English summary

Sentara Infusion Services is recalling IMIPENEM/CILASTATIN 2000MG in normal saline 400ML, an antibiotic injectable medication for IV administration. Seven bags were dispensed to patients nationwide.

The recall was issued due to lack of sterility assurance. The affected product has a Beyond Use Date of December 25-30, 2022.

The recalled product

Product
IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
Manufacturer
Sentara Infusion Services
Category
Drug — Injectable Antibiotic
Hazard
  • sterility-failure
  • 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.

Related recalls

Same category