Drug Enforcement D-1547-2022

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

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Status

Ongoing

Classification

Class II

Report Date

October 5, 2022

Termination Date

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Product Information

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
Product quantity
18,145 bottles
Reason for recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide and Puerto Rico

Location & Firm

Recalling firm
Akorn, Inc.
Address
5605 Centerpoint Ct Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1547-2022
Event ID
90880
Recall initiation date
September 21, 2022
Center classification date
September 28, 2022
Code info
Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
More code info
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