Drug & medication recalls Moderate risk

Cefepime for Injection recalled over sterility concerns

Recall date
May 15, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Astral SteriTech Private Ltd. recalls Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Recall number
D-0605-2023
FDA classification
Class II
Brand / firm
Astral SteriTech Private Ltd.
Sold / distributed
Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10

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