Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance
Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.
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 injectable medication with lack of sterility assurance. No illnesses or injuries reported. Lack of sterility in injectable medications poses risk of serious infection if contaminated units were administered, fitting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling compounded CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML syringes due to lack of sterility assurance. The recall involves 8 syringes with a beyond-use date of December 29-31, 2022.
The product is an injectable medication combining an antibiotic with an anticoagulant. Injectable medications must meet strict sterility requirements to prevent infection. The recall was issued because the syringes may not meet required sterility assurance standards.
The affected syringes were dispensed to patients nationwide. Sentara Infusion Services is located in Chesapeake, Virginia.
If you received this product, contact your healthcare provider or Sentara Infusion Services immediately to determine if you were affected and discuss any appropriate follow-up care.
The recalled product
- Product
- CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- infection-risk
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 29-31
- 2022
Distribution
Distributed nationwide across the United States.
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