Drug recall D-0139-2020

Class II Terminated reported Oct 16, 2019

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.

Lots and codes

Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020

Recall details

Recalling firm
Mylan Laboratories Limited (Sterile Products Division), Bangalore, N/A
Quantity
19,165 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 7, 2019
Terminated
March 9, 2023

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