Tobramycin 660mg Injectable Antibiotic Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Tobramycin 660mg injectable antibiotic used for home infusion therapy due to lack of sterility assurance. Two bags were dispensed to patients nationwide.
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 a Class II recall of an injectable antibiotic. Although no illnesses or injuries have been reported in the source material, lack of sterility assurance in an intravenous medication presents a direct risk of serious infection and qualifies as a risk-of-harm product under the High category.
Plain-English summary
Sentara Infusion Services is recalling Tobramycin 660mg in Normal Saline (NS) 66mL, a prescription antibiotic used for home infusion therapy. The medication is administered using the HomePump infusion device. Two bags with a beyond-use date of December 24, 2022 were dispensed to patients nationwide.
The recall was initiated due to lack of sterility assurance. Tobramycin is an injectable antibiotic that must be sterile to ensure patient safety. If the product is contaminated, patients could be at risk of serious infections.
Patients who received this medication should contact their healthcare provider to discuss any concerns about their medication and to determine if their supply is affected.
This is a Class II recall, FDA recall number D-0317-2023. For additional information, contact Sentara Home Infusion Pharmacy Services at 535 Independence Parkway, Suite 300, Chesapeake, VA 23320.
The recalled product
- Product
- TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Hazard
- contamination
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 (3)
- Beyond Use Date
- ecember 24
- 2022
Distribution
Distributed nationwide across the United States.
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