D-0774-2022 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
April 27, 2022
Initiation Date
April 7, 2022
Termination Date
May 23, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33,893 vials

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023