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.
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: 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
- Affected units
- 7
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.
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.
See all 53 products in this recall →Related recalls
Same manufacturer · Sentara Infusion Services
See all →- HighEthanol 70% Syringes Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighDaptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighFluconazole 200mg injection recalled due to sterility concerns
FDA (Drugs) · 2023-02-22
- HighMeropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighCefoxitin injectable bags recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-02-22
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereAmikacin Sulfate Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2021-08-25
- SevereSentara Recalls Gentamicin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Ampicillin/Sulbactam Bags Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Mycamine Micafungin Sodium Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns
FDA (Drugs) · 2016-02-03