Ceftriaxone Injectable Antibiotic Recalled Nationwide for Sterility Assurance Deficiency
Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 without any reported illnesses or hospitalizations. The hazard involves inadequate sterility assurance for an injectable medication, which meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling 66,125 vials of Ceftriaxone for Injection, USP 250 mg per vial, an injectable antibiotic manufactured for Xellia Pharmaceuticals USA, LLC. The product has been distributed nationwide within the United States. The recall has been issued due to lack of assurance of sterility in the manufacturing process.
Ceftriaxone is administered by injection to treat bacterial infections. As an injectable medication, it must be sterile to be safe for use. The recall addresses a deficiency in manufacturing quality assurance controls that verify sterility of the product.
Healthcare providers and pharmacies should stop distribution of affected vials and quarantine them. Patients who have received injections of this recalled product should consult their healthcare provider if they have concerns about their medication.
The recalled product
- Product
- Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 66,125
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.
See all 52 products in this recall →Related recalls
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