Cefepime for Injection recalled due to sterility assurance failure
Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.
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 involving injectable medication with a sterility assurance failure. No illnesses or injuries have been reported in the source text, making this a theoretical contamination hazard despite the potential for serious infection if the product were administered. This fits the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd., manufacturing for Xellia Pharmaceuticals USA LLC, is recalling Cefepime for Injection, USP 1 gram per vial (NDC 70594-089-02) due to lack of assurance of sterility.
The recall affects 550,160 vials distributed nationwide within the United States. All lots within the product's expiry date are included in this recall.
The issue is that these injectable vials cannot be assured to maintain proper sterility. Healthcare providers and patients who may have access to affected product should consult with their pharmacist or healthcare provider before use.
The FDA has designated this as a Class II recall. Affected individuals can contact the FDA or the manufacturer for additional information and guidance.
The recalled product
- Product
- Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 550,160
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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