Levothyroxine Injectable Syringes Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling levothyroxine injectable syringes dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if they received this product.
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 injectable drug recall with lack of sterility assurance, presenting infection risk from potential contamination. No illnesses or injuries have been reported to date.
Plain-English summary
Sentara Infusion Services is recalling levothyroxine 25 micrograms in normal saline syringes (1.25 mL per syringe) due to lack of sterility assurance. Levothyroxine is a thyroid hormone replacement medication administered by injection. The syringes have a beyond-use date of December 29, 2022.
The recall was initiated because the syringes cannot be guaranteed to meet sterility standards. Lack of sterility assurance on injectable products creates a risk of contamination and potential infection. Seven syringes were included in this recall.
The product was dispensed to patients nationwide. If you received this levothyroxine injection, contact your healthcare provider or pharmacist immediately to determine if you were affected and what steps you should take. Do not discard the medication without guidance from your healthcare provider.
The recalled product
- Product
- LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Compounded
- Affected units
- 7
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
- 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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