NDC 72189-609
Rizatriptan Benzoate ODT 10 mg tablet, orally disintegrating
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-094.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Oct 18, 2021 · Class III · Macleods Pharma Usa, Inc
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Lots: Lot #: BRL2102A, BRL2103A, exp. date 04/2025 - Oct 18, 2021 · Class III · Macleods Pharma Usa, Inc
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Lots: Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rizatriptan: every company that makes it
- Form
- tablet, orally disintegrating, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA203146
- On the market since
- Jan 20, 2025
- Package NDCs
72189-609-18- Official label
- DailyMed (National Library of Medicine), updated Mar 17, 2026
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