Recall: D-1234-2015

Class II - Potentially Harmful

Class IIClassification

2015-06-04Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

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

Distribution

Nationwide,Hawaii, and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.