NDC 71610-231
Allopurinol 300 mg tablet
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. 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
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, 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
- Apr 29, 2015
- Package NDCs
71610-231-60- Official label
- DailyMed (National Library of Medicine), updated Feb 12, 2019
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