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Recall Observatory FDA recall evidence

Drug product

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

D-1547-2022

September 21, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90880
Status
Ongoing
Classification
Class II
Quantity
18,145 bottles
Official record key
drug-enforcement:D-1547-2022

Official wording

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

Code information: Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024

Distribution pattern: USA Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed impurities/degradation specifications