Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
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: Class II FDA recall for injectable medication with potential sterility issues presents risk of serious harm, but no illnesses or injuries are reported in the source. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ceftriaxone for Injection, USP 500 mg per vial is being recalled. The affected product has NDC number 70594-095-02 and was manufactured by Astral SteriTech Private Ltd. for Xellia Pharmaceuticals USA, LLC. Approximately 66,175 vials have been distributed nationwide within the United States.
The recall was initiated due to lack of assurance of sterility. The FDA has classified this as a Class II recall, indicating a serious potential health concern. All affected lots remain within their expiration dates.
Patients and healthcare providers who received or dispensed this medication should consult the patient's healthcare provider regarding appropriate action. Healthcare facilities should verify whether they have received vials with NDC 70594-095-02 and contact Xellia Pharmaceuticals or the FDA for further guidance.
The recalled product
- Product
- Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injection / Injectable
- Hazard
- sterility-assurance
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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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