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.
Reported: October 5, 2022 Initiated: September 21, 2022 #D-1548-2022
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.
Reason for Recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 177,439 bottles
- Distribution
- USA Nationwide and Puerto Rico
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 177,439 bottles.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Moderate. Recall number: D-1548-2022.
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