Drug product
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
D-1547-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,145 bottles
- Official record key
drug-enforcement:D-1547-2022
Official wording
Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Code information: Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Distribution pattern: USA Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications