Cefepime for Injection Vials Recalled Over Sterility Concerns
Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.
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 an injectable medication with confirmed lack of sterility assurance, which presents a risk of serious infection and harm. No illnesses, injuries, or deaths have been reported in the source text, making this a high-risk product without confirmed adverse events.
Plain-English summary
Cefepime for Injection, USP 2 grams per vial, is being recalled nationwide. Manufactured by Astral SteriTech Private Ltd. and distributed for Civica Inc., the product (NDC 72572-058-10) is affected by a lack of assurance of sterility. This means the manufacturer cannot confirm that the product meets required sterility standards for injectable medications.
All lots within their expiration dating are included in this recall, totaling 124,010 vials distributed nationwide. Injectable medications must maintain complete sterility to be safe for patient use.
Patients and healthcare providers who possess this product should not use it. Affected individuals should contact their healthcare provider for guidance regarding alternative treatments.
The recalled product
- Product
- Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Hazard
- Affected units
- 124,010
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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