Cefazolin Antibiotic Injections Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Cefazolin antibiotic injections due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed 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: FDA Class II recall of an injectable medication with lack of sterility assurance. No illnesses or injuries are reported in the source. The hazard represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Sentara Infusion Services is recalling Cefazolin antibiotic injections in multiple formulations (12GM/600mL, 2GM/100mL, 2GM/20mL syringe, and 3GM/150mL) due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed nationwide, with beyond-use dates of December 25-31, 2022.
Cefazolin is an antibiotic used to treat bacterial infections. Lack of sterility assurance in injectable medications presents a risk of microbial contamination, which could cause serious infection if administered to patients.
The affected products were dispensed to patients nationwide from Sentara Home Infusion Pharmacy Services located in Chesapeake, Virginia. Patients who received these products should contact their healthcare provider or pharmacist immediately to determine whether they were affected and to discuss appropriate next steps.
The recalled product
- Product
- CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
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 By: December 25-31
- 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.
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