Ampicillin IV Infusion Bags Recalled for Lack of Sterility Assurance
Sentara Home Infusion Pharmacy Services is recalling 14 bags of Ampicillin 8GM in NS 400ML due to lack of sterility assurance. The affected batches were distributed nationwide to 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: FDA classified this as Class II. No illnesses or deaths have been reported. However, the lack of sterility assurance in an intravenous antibiotic product presents a significant risk to patient safety, as non-sterile injected medications can cause serious infections.
Plain-English summary
Sentara Home Infusion Pharmacy Services is recalling Ampicillin 8GM in NS 400ML, an antibiotic administered intravenously via Curlin pump. The recall affects 14 bags with Beyond Use Dates between December 25 and December 30, 2022. The product is being recalled due to lack of sterility assurance—the manufacturer cannot guarantee the product maintains required sterility standards, which is essential for intravenous medications.
The affected product was dispensed nationwide to patients. Patients who received this medication should consult their healthcare provider immediately if they experience signs of infection, such as fever, chills, or unusual pain at the infusion site. Patients should not use any remaining doses and should contact Sentara Infusion Services with questions about whether they received affected product.
The recalled product
- Product
- AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug
- 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 25-December 30
- 2022
Distribution
Distributed nationwide across the United States.
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