D-1547-2022 Class II Ongoing
FDA drug recall D-1547-2022 was initiated by Akorn, Inc. on Sep 21, 2022 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). The recall status is ongoing. Affected quantity: 18,145 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 5, 2022
- Initiation Date
- Sep 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,145 bottles
Product Description
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Reason for Recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Distribution Pattern
USA Nationwide and Puerto Rico
Code Information
Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1547-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026