Drug 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
D-0774-2022
Product summary
- Event
- Event 89910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,893 vials
- Official record key
drug-enforcement:D-0774-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Code information: Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification