Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Recall Number: D-0139-2020

Firm: Mylan Laboratories Limited (Sterile Products Division)

Classification: Class II

Status: Terminated

Report Date: 20191016

Initiation Date: 20191007

Termination Date: 20230309

Reason for Recall

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Product Description

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.