Akorn, Inc.: Drug Recall
Recall #D-1548-2022 · 09/21/2022
Class II: Risk
Recall Details
- Recall Number
- D-1548-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Ongoing
- Date Initiated
- 09/21/2022
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177,439 bottles
Reason for Recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Product Description
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
Distribution Pattern
USA Nationwide and Puerto Rico
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.