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.
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 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
- Affected units
- 8
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.
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 defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- HighSentara Recalls Cefazolin Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-02-03
- SevereceFAZolin Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-10-06
- SevereSentara Recalls Ceftriaxone Infusions Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- HighCefazolin Syringes Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-05-01
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27