RIFAMPIN Recall D-1547-2022
Description: Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
RIFAMPIN Recall D-1547-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1547-2022 |
Event ID | 90880 |
Brand | RIFAMPIN |
Generic Name | RIFAMPIN |
Manufacturer | RIFAMPIN |
Original Package? | 1 |
Active Substance | RIFAMPIN |
Drug Route | ORAL |
Distribution | USA Nationwide and Puerto Rico |
Quantity | 18,145 bottles |
Recall Reason | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). |
Drug Classification | Class II |
Drug Code Info | 20221005 |
Product NDC | 61748-015 61748-018 |
Product NUI | N0000175500 M0019113 |
Pharma Class (EPC) | Rifamycin Antibacterial [EPC] |
Pharma Class (CS) | Rifamycins [CS] |
Recall Initiation Date | 20220921 |
Report Date | 20221005 |
Classification Date | 20220928 |
Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
Recalling Firm | Akorn, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | VJT6J7R4TR |
Drug Application Number | ANDA065028 |
Structured Product Labeling (SPL ID) | eb950d35-ef45-4f4b-a183-982d7c4d48a7 |
Structured Product Labeling (SPL Set ID) | 26a2dbca-5090-4f6c-99ed-e11a70bb5af0 |
Similar To |