FDA-Drug2015-07-22Class II

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

Fresenius Kabi USA, LLC
Hazard

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

Sold states
Nationwide,Hawaii, and Puerto Rico
Affected count
7,593 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1234-2015

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