FDA-Drug2022-10-05Class II
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.
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
177,439 bottles
Manufactured in
5605 Centerpoint Ct Ste A, N/A, Gurnee, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1548-2022Don't want to check this manually?
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