Recalls / Class II
Class IID-1547-2022
Product
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
- Affected lot / code info
- Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Why it was recalled
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 18,145 bottles
- Distribution pattern
- USA Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2022-09-21
- FDA classified
- 2022-09-28
- Posted by FDA
- 2022-10-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1547-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.