NDC 71610-344
Buspirone Hydrochloride 15 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 16729-203.
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 |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105483, Exp. Date 7/31/2024; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105472, Exp. Date 4/30/2024; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105551, Exp. Date 7/31/2024;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Buspirone: every company that makes it
- Form
- tablet
- Strength
- 15 mg
- Approval
- ANDA ANDA202557
- On the market since
- Dec 15, 2016
- Package NDCs
71610-344-53- Official label
- DailyMed (National Library of Medicine), updated Oct 7, 2019
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