Status
Ongoing
Drug Enforcement D-1548-2022
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
1 Views
Classification
Class II
Report Date
October 5, 2022
Termination Date
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Product Information
- 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.
- Product quantity
- 177,439 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
- —
- 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
- —
Codes & Dates
- Recall number
- D-1548-2022
- Event ID
- 90880
- Recall initiation date
- September 21, 2022
- Center classification date
- September 28, 2022
- Code info
- Lot#: a) 3192827, Exp 10/31/2022; 3196136, Exp 12/31/2022; 3202198, Exp 07/31/2023; 3203658, Exp 07/31/2023; 3209114, Exp 11/30/2023; 3203851, Exp 02/29/2024; b) 3191254, Exp 09/30/2022; 3192820, Exp 09/30/2022; 3192822, Exp 10/31/2022; 3192824, Exp 10/31/2022; 3192825, Exp 10/31/2022; 3196141, Exp 01/31/2023; 3196143, Exp 02/28/2023; 3203870, Exp 11/30/2023; 3203871, Exp 02/29/2024; c) 3190636, Exp 09/30/2022; 3192813, Exp 09/30/2022; 3196132, Exp 12/31/2022; 3196133, Exp 12/31/2022; 3196138, Exp 01/31/2023; 3199702, Exp 03/31/2023; 3199703, Exp 03/31/2023
- More code info
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