FDA-Drug2019-10-16Class II

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

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.

Sold states
Nationwide in the USA
Affected count
19,165 vials
Manufactured in
Opp. Iim-B, Bilekahalli , Bannerghatta Road, N/A, Bangalore, N/A, India
Products
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Official notice

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

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