NDC 53002-6431
rifampin 300 mg capsule
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-659.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Chhatrapati Sambhajinagar, India | Makes it and packages it | Problems found, fixed voluntarilyMar 15, 2024 · 5 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Jan 5, 2024 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug and Failed Impurities/Degradation Specifications
Lots: A200816 exp 1/2024 A201248 exp 3/2024 - Jan 5, 2024 · Class II · Lupin Pharmaceuticals Inc.
Subpotent Drug and Failed Impurities/Degradation Specifications
Lots: A200817 exp 1/2024 - Dec 12, 2022 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Lots: Lot # A200171, Exp 12/2023 - Jul 28, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Lots: Lot #A200170, exp. date December 2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rifampin: every company that makes it
- Form
- capsule
- Strength
- 300 mg
- Approval
- ANDA ANDA090034
- On the market since
- Jan 8, 2014
- Package NDCs
53002-6431-253002-6431-353002-6431-653002-6431-7- Official label
- DailyMed (National Library of Medicine), updated Nov 23, 2023
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