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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 4
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.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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