NDC 72189-316
Rizatriptan Benzoate 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-261.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jul 9, 2025 · Class II · Ascend Laboratories, LLC
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Lots: Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027 - Jul 9, 2025 · Class II · Ascend Laboratories, LLC
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Lots: Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: Nov…
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, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA203269
- On the market since
- Jan 20, 2022
- Package NDCs
72189-316-18- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
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