Ceftriaxone Injectable Recalled Due to Lack of Sterility Assurance
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
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 a Class II drug recall involving a risk-of-harm product—a sterile injectable lacking assurance of sterility poses a serious potential for harm. However, no illnesses or injuries have been reported, placing this in the High category per the rubric criterion for "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Ceftriaxone for Injection, USP 1 gram per vial is being recalled nationwide. Manufactured by Astral SteriTech Private Ltd. and distributed for Piramal Critical Care, the recall includes approximately 73,475 vials distributed within the United States. All affected lots are still within their expiration dates.
The recall was initiated due to lack of assurance of sterility. The manufacturer could not confirm that the vials meet the required sterility standards for injectable medications. As a sterile pharmaceutical product, ceftriaxone must meet strict sterility requirements to ensure patient safety.
Healthcare providers and institutions that received affected vials should cease use immediately. Patients and healthcare professionals with questions about affected medication should contact the manufacturer or their healthcare provider.
The recalled product
- Product
- Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Antibiotic Injection
- Hazard
- lack-of-sterility
- microbial-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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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