Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.
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 intravenous antibiotic with potential for serious infection due to lack of sterility assurance. The FDA classification is Class II, no illnesses or injuries have been reported in the source, and the hazard is theoretical rather than confirmed, meeting the criterion for Score 3.
Plain-English summary
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM in sodium chloride 100mL intravenous infusion bags. The product does not meet sterility assurance standards, creating a potential risk to patients receiving this antibiotic via home infusion therapy.
The recalled product was dispensed nationwide to patients through home infusion services. The affected product has a Beyond Use Date of December 25 through December 30, 2022.
Patients who received this medication should discontinue use immediately and contact their healthcare provider or Sentara Infusion Services. Healthcare providers should advise affected patients and consider alternative antibiotic therapy as appropriate.
The recalled product
- Product
- Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Hazard
- sterility-assurance
- infection-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-December 30
- 2022
Distribution
Distributed nationwide across the United States.
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