Drug product

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

D-0139-2020

October 07, 2019

Class II

Product summary

Firm: Mylan Laboratories Limited (Sterile Products Division)
Event: Event 83914
Status: Terminated
Classification: Class II
Quantity: 19,165 vials
Official record key: drug-enforcement:D-0139-2020

Official wording

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

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

Distribution pattern: Nationwide in the USA

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications