Cefepime Injectable Antibiotic Recalled for Sterility Assurance Failure
Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was 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 medication due to lack of sterility assurance. With no reported illnesses or injuries and only theoretical contamination risk, this meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling 964,420 vials of Cefepime for Injection, USP 2 grams per vial (NDC 70594-090-02), manufactured for Xellia Pharmaceuticals USA, LLC in Buffalo Grove, Illinois. All lots currently within their expiration dates are included in the recall.
The recall was initiated because the manufacturer could not assure the sterility of the product. Sterility is essential for the safe use of injectable medications, as non-sterile injectables carry a risk of contamination and infection.
The affected product was distributed nationwide within the United States to healthcare facilities. No illnesses or injuries have been reported in connection with this recall at this time.
Healthcare providers and patients who have received this medication should contact their medication supplier, healthcare provider, or the recalling firm with questions about this recall.
The recalled product
- Product
- Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Antibiotic Injection
- Affected units
- 964,420
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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