PlainRecalls
FDA Drug Moderate Class II Terminated

Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

Reported: April 27, 2022 Initiated: April 7, 2022 #D-0774-2022

Product Description

Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

Details

Recalling Firm
Mylan Pharmaceuticals Inc
Units Affected
33,893 vials
Distribution
Nationwide in the USA
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60. Recalled by Mylan Pharmaceuticals Inc. Units affected: 33,893 vials.
Why was this product recalled?
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 27, 2022. Severity: Moderate. Recall number: D-0774-2022.