Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, B...
FDA Recall #D-0609-2023 — Class II — May 15, 2023
Product Description
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Astral SteriTech Private Ltd. — Vadodara, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
550,160 vials
Distribution
Nationwide within the United States
Code Information
All lots within expiry.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated