FDA recall D-1234-2015

Product

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

Distribution

Nationwide,Hawaii, and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-06-04

Report date

2015-07-22

Termination date

2016-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

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