Ceftriaxone for Injection Recalled for Lack of Sterility Assurance
Xellia Pharmaceuticals is recalling 739,750 vials of Ceftriaxone for Injection, USP due to lack of assurance of sterility. All affected lots nationwide should not be used.
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: FDA Class II recall of a high-risk injectable drug with inability to assure sterility. Although no illnesses or injuries have been reported, this involves a risk-of-harm product where sterility assurance is critical for injectable pharmaceuticals, fitting the High severity criterion.
Plain-English summary
Xellia Pharmaceuticals USA, LLC is recalling Ceftriaxone for Injection, USP, 1 grams per vial (NDC 70594-096-02) manufactured by Astral SteriTech Private Ltd. The recall affects 739,750 vials distributed nationwide within the United States. All lot numbers within expiry are included in this recall.
The reason for the recall is lack of assurance of sterility. Injectable medications must meet strict sterility standards to ensure patient safety. This recall was issued because the manufacturer cannot provide assurance that the affected vials meet required sterility standards.
Healthcare providers should quarantine affected inventory and contact their pharmaceutical suppliers regarding replacement product. Patients who may have received this medication should contact their healthcare provider to discuss alternative options. The affected vials should not be dispensed or used.
The recalled product
- Product
- Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 739,750
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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