FDA-Drug2022-10-05Class II

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

Akorn, Inc.
Hazard

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Sold states
USA Nationwide and Puerto Rico
Affected count
18,145 bottles
Manufactured in
5605 Centerpoint Ct Ste A, N/A, Gurnee, IL, United States
Products
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1547-2022

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