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Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals U...

FDA Recall #D-0610-2023 — Class II — May 15, 2023

Recall #D-0610-2023 Date: May 15, 2023 Classification: Class II Status: Terminated

Product Description

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02

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

964,420 vials

Distribution

Nationwide within the United States

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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