NDC 61919-471
Allopurinol 300 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Accord Healthcare Inc.'s NDC 16729-135.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jan 12, 2023 · Class II · Accord Healthcare, Inc.
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Lots: Lots: R2200455, R2200456 Exp. 03/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Allopurinol: every company that makes it
- Form
- tablet
- Strength
- 300 mg
- Approval
- ANDA ANDA203154
- On the market since
- Mar 14, 2018
- Package NDCs
61919-471-30- Official label
- DailyMed (National Library of Medicine), updated Jan 18, 2021
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