Hydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.
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 an FDA Class II recall of an injectable pharmaceutical product with a theoretical hazard (lack of sterility assurance) that poses risk of infection. However, no illnesses or injuries have been reported, which limits the score to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes due to lack of sterility assurance. The recalled product includes two formulations: Hydrocortisone 2 mg in 0.2 mL normal saline syringes and 9 mg in 2 mL normal saline syringes. The affected product lot consisted of 32 syringes with a Beyond Use Date of December 24-31, 2022.
The affected syringes were dispensed to patients nationwide through Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia.
Patients who have or may have received affected syringes should contact their physician immediately. Do not use affected product. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Steroid
- Hazard
- Affected units
- 32
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 24-31
- 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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