The Recall Desk
HighFDA (Drugs)·D-0290-2023·Announced 2023-02-22

Dobutamine Injectable Medication Recalled Due to Lack of Sterility Assurance

Dobutamine injectable medication distributed by Sentara Infusion Services has been recalled due to lack of sterility assurance. If you received this medication, contact your healthcare provider for guidance.

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 medication with lack of sterility assurance, representing a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been documented.

Plain-English summary

Dobutamine, an injectable medication administered via home infusion pump, has been recalled by Sentara Infusion Services. The recall involves two product formulations: 1080mg in 270ml D5W solution and 760mg in 190ml D5W solution, affecting four units total.

The recall was initiated due to lack of sterility assurance in the medication.

The affected product was dispensed to patients nationwide with a beyond use date of December 29, 2022.

Patients who received this medication should contact their healthcare provider or Sentara Infusion Services for further instructions regarding their treatment.

The recalled product

Product
DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Hazard
  • contamination-risk
  • injectable-safety

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 29
  • 2022

Distribution

Distributed nationwide across the United States.