Mylan Laboratories Limited (Sterile Products Division) recalls Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 6…

Recall date

October 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0139-2020

FDA classification

Class II

Brand / firm

Mylan Laboratories Limited (Sterile Products Division)

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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