Ceftriaxone injection vials recalled for lack of sterility assurance
Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.
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 an FDA Class II recall involving lack of sterility assurance in an injectable antibiotic. While no illnesses or deaths have been reported, the product poses a significant risk of infection to patients due to potential contamination from non-sterile administration.
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 66,250 vials of Ceftriaxone for Injection, USP 250 mg per vial, manufactured for Piramal Critical Care. The recall was initiated due to lack of assurance of sterility in the recalled vials.
Ceftriaxone is an injectable antibiotic used to treat bacterial infections. If administered from non-sterile vials, the medication could introduce contamination that poses a risk of infection to patients.
This FDA Class II recall affects vials distributed nationwide within the United States. All lots within the product's expiry period are included in the recall. Healthcare facilities and patients should not use affected vials.
Patients and healthcare providers should consult the FDA recall notice or contact Astral SteriTech for additional information about the recall.
The recalled product
- Product
- Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 66,250
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.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. 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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