Injectable Ceftriaxone Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
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 involving a lack of assurance of sterility in an injectable drug product. No illnesses or injuries have been reported; the hazard is theoretical based on manufacturing controls. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Astral SteriTech Private Ltd. is recalling Ceftriaxone for Injection, USP, 2 grams per vial (NDC 70594-097-02), across all lots currently within expiration. Approximately 243,825 vials were distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility in the manufacturing process. This means the manufacturer cannot confirm that the product meets required sterility standards for injectable drugs.
The recalled product was distributed to healthcare facilities and pharmacies nationwide. No illnesses or injuries related to this recall have been reported.
Consumers and healthcare providers in possession of the recalled product should not use it. Contact your pharmacy or healthcare provider for instructions on returning the medication for proper disposal. Anyone who has received an injection from the recalled product should consult with their healthcare provider if they develop any unusual symptoms.
The recalled product
- Product
- Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 243,825
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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