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
Recalled October 16, 2019 · FDA recall D-0139-2020 · Mylan Laboratories Limited (Sterile Products Division)
Hazard
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. · FDA Class II
Units
19,165 vials
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Product
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Manufacturer(s)
Mylan Laboratories Limited (Sterile Products Division)
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →