Methylprednisolone steroid injections recalled for lack of sterility assurance
Sentara Infusion Services is recalling 27 syringes of Methylprednisolone steroid due to lack of sterility assurance. The product was distributed nationwide to patients with a beyond-use date of December 29-31, 2022.
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: The FDA classified this as a Class II recall with no reported illnesses or injuries. However, sterility failure on an injectable medication represents a significant risk of harm to patients, placing this in the High (Score 3) category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling 27 syringes of Methylprednisolone 12MG in normal saline, a corticosteroid medication, that were dispensed to patients nationwide. The syringes were prepared and distributed by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia.
The recall was initiated due to a lack of sterility assurance on the product. Sterility is critical for injectable medications.
The affected syringes have a beyond-use date of December 29-31, 2022. If you have received this medication, contact your healthcare provider or pharmacist to confirm whether you were affected and to discuss any appropriate follow-up.
The recalled product
- Product
- Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Steroid
- Hazard
- contamination
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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