PlainRecalls
FDA Drug Moderate Class II Terminated

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Reported: July 22, 2015 Initiated: June 4, 2015 #D-1234-2015

Product Description

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Reason for Recall

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
7,593 vials
Distribution
Nationwide,Hawaii, and Puerto Rico
Location
Lake Zurich, IL

Frequently Asked Questions

What product was recalled?
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20. Recalled by Fresenius Kabi USA, LLC. Units affected: 7,593 vials.
Why was this product recalled?
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Which agency issued this recall?
This recall was issued by the FDA Drug on July 22, 2015. Severity: Moderate. Recall number: D-1234-2015.