PlainRecalls
FDA Drug Moderate Class II Terminated

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

Reported: May 24, 2023 Initiated: May 15, 2023 #D-0620-2023

Product Description

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
7,940 bottles
Distribution
Nationwide within the United States
Location
Vadodara, N/A

Frequently Asked Questions

What product was recalled?
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01. Recalled by Astral SteriTech Private Ltd.. Units affected: 7,940 bottles.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0620-2023.