Amikacin Injectable Antibiotic Lacks Sterility Assurance, Nationwide Recall
Sentara Infusion Services is recalling 7 bags of Amikacin 450MG injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving IV infusions.
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 involving an injectable medication with lack of sterility assurance poses a significant risk of infection if contamination occurred. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling Amikacin 450MG in Normal Saline 45ML, an antibiotic medication administered intravenously through a HOMEPUMP infusion pump. The recall involves 7 bags of the product that were dispensed to patients nationwide with beyond-use dates of December 28-30, 2022.
The recall was initiated due to lack of sterility assurance in the manufacturing process. Amikacin is administered directly into the bloodstream, and sterility is critical to prevent serious infections.
Patients who received this medication should contact Sentara Infusion Services or their healthcare provider immediately if they experience signs of infection such as fever, chills, or unexplained illness. Healthcare providers should review patient records to identify any patients who received affected units and monitor them closely.
The recalled product
- Product
- Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Hazard
- sterility-failure
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 28 - December 30
- 2022
Distribution
Distributed nationwide across the United States.
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