FDA recall D-0139-2020

Mylan Laboratories Limited (Sterile Products Division) · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-10-07
Report date: 2019-10-16
Termination date: 2023-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bangalore, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2020