The Recall Desk
HighFDA (Drugs)·D-0314-2023·Announced 2023-02-22

Penicillin Intravenous Antibiotic Recalled Over Lack of Sterility Assurance

Sentara Infusion Services is recalling eight bags of intravenous penicillin antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide.

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 antibiotic with lack of sterility assurance. No illnesses or hospitalizations reported. This is a risk-of-harm product where potential injury has not yet been reported, meeting the High severity threshold.

Plain-English summary

Sentara Infusion Services is recalling eight bags of penicillin intravenous antibiotic due to lack of sterility assurance. The recalled product consists of three formulations: 40MU in 5% dextrose (D5W) 400ML for continuous infusion, 40U in D5W 400ML for continuous infusion, and 48MU in D5W 480ML. All affected bags have a beyond-use date of December 25-31, 2022.

The recalled medication was dispensed to patients nationwide. Patients who received this antibiotic should contact their healthcare provider about this recall.

The recalled product

Product
PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, 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
Category
Drug — Injectable Antibiotic
Hazard
  • 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 25-31
  • 2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category