FDA recall D-0774-2022

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-04-07

Report date

2022-04-27

Termination date

2023-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2022