Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.
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 recall for lack of sterility assurance in an injectable antibiotic. This is a risk-of-harm product where no illnesses or injuries have been reported, but the sterility concern is substantive and concrete.
Plain-English summary
Astral SteriTech Private Ltd. is recalling Ceftriaxone for Injection, USP, 2 grams per vial (NDC 66794-214-42) due to lack of assurance of sterility. The recall affects 41,500 vials distributed nationwide within the United States.
Ceftriaxone is a third-generation cephalosporin antibiotic used to treat serious bacterial infections. Sterility is a critical requirement for all injectable medications. The manufacturer cannot provide adequate assurance that the product meets sterility standards.
All lots of the product within their expiry dates are included in this recall. The affected medication has been distributed nationwide.
Consumers and healthcare facilities who have this product should cease use and consult with their healthcare provider or the manufacturer regarding the recall. Healthcare facilities should follow their established procedures for managing recalled medications.
The recalled product
- Product
- Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- lack-of-sterility
- contamination-risk
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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