Ceftriaxone Injection Recalled Over Sterility Assurance Defect
Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.
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 of an injectable pharmaceutical due to lack of sterility assurance. While the defect poses potential harm, no illnesses or injuries have been reported in the source text. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Astral SteriTech Private Ltd. has issued a recall of Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package (NDC 70594-098-01), manufactured for distribution by Xellia Pharmaceuticals USA, LLC. The recall covers approximately 7,940 pharmacy bulk package bottles, with all affected lots remaining within their expiration dates.
The product has been recalled due to lack of assurance of sterility. The U.S. Food and Drug Administration has classified this as a Class II recall.
The affected product was distributed nationwide throughout the United States. Healthcare providers and patients should be aware of this recall and may contact the FDA or the recalling firm for additional information.
The recalled product
- Product
- Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 7,940
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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