RecallRadar

FDA Drug recall D-0610-2023

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 7059…

On 2023-05-24 the FDA classified a Class II recall of Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 7059… by Astral Steritech Private, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0610-2023
ClassificationClass II
Statusterminated
Initiated2023-05-15
Published2023-05-24
Last updated2026-09-13 11:52 UTC
CompanyAstral Steritech Private
DistributionUS

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

Reason

Lack of Assurance of Sterility

Identifiers

code_infoAll lots within expiry.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0610-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.