Ertapenem Injectable Antibiotic Bags Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 22 bags of Ertapenem (Invanz) injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving home infusion therapy.
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 of an injectable antibiotic product with lack of sterility assurance. No illnesses or injuries reported. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling 22 bags of Ertapenem (Invanz) 1GM in 100mL saline solution, an injectable antibiotic intended for use with home infusion pumps. The recalled product has a Beyond Use Date of December 24–31, 2022.
The recall is due to lack of sterility assurance in the recalled bags. Sterility is critical for injectable products, as non-sterile injectables carry the risk of serious infection or other adverse health outcomes.
The affected product was dispensed to patients nationwide by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia.
Patients who received this medication should contact their healthcare provider or Sentara Infusion Services to confirm whether they received any of the recalled product and for guidance on next steps. Do not use any of the recalled medication.
The recalled product
- Product
- Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Hazard
- lack-of-sterility
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 24-31
- 2022
Distribution
Distributed nationwide across the United States.
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