The Recall Desk
HighFDA (Drugs)·D-0292-2023·Announced 2023-02-22

Ethanol 70% Syringes Recalled Due to Lack of Sterility Assurance

Sentara Infusion Services is recalling 17 units of ETHANOL 70% 0.5ML syringes distributed nationwide due to lack of sterility assurance. The syringes may not meet required sterility standards for safe injection.

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 for sterile pharmaceutical with lack of sterility assurance. No hospitalizations or illnesses reported in source text; the hazard is contamination risk. Per rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Sentara Infusion Services is recalling ETHANOL 70% 0.5ML syringes distributed nationwide to patients. The recall affects 17 units dispensed by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia. The product is being recalled due to lack of sterility assurance, meaning the syringes may not meet required sterility standards for safe injection use.

Patients who received these syringes should contact their healthcare provider or pharmacy immediately. Affected patients may be identified by the Beyond Use Date of December 25-31, 2022 on the product label. Healthcare providers should verify whether dispensed units fall within this date range and take appropriate action.

The recalled product

Product
ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Hazard
  • contamination
  • 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 25-31
  • 2022

Distribution

Distributed nationwide across the United States.