The Recall Desk
HighFDA (Drugs)·D-0315-2023·Announced 2023-02-22

Piperacillin/Tazobactam Injectable Antibiotic Recalled Due to Lack of Sterility Assurance

Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections due to lack of sterility assurance. The 78-unit recall affects 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: This is a risk-of-harm product where no illnesses or injuries have been reported, per the rubric's definition of High severity. An injectable antibiotic lacking sterility assurance poses a risk of contamination.

Plain-English summary

Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections in multiple concentrations (3.375 GM in 50 ML, 4.5 GM in 100 ML, 18 GM in 267 ML, 27 GM in 400 ML, and 36 GM in 533 ML) due to lack of sterility assurance. A total of 78 bags were affected.

The medication was dispensed to patients nationwide. Affected units have beyond-use dates of December 25-31, 2022. No illnesses or injuries have been reported.

Patients who received this medication should contact their healthcare provider or pharmacy to discuss their treatment. Healthcare providers should not dispense any affected units.

The recalled product

Product
PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, C
Manufacturer
Sentara Infusion Services
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 25-31
  • 2022

Distribution

Distributed nationwide across the United States.