Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.
NDC 50436-2010
Buspirone Hydrochloride 7.5 mg tablet
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Accord Healthcare Inc.'s NDC 16729-201.
Where the pills inside were made
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Feb 7, 2023 · Class II · Terminated
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 · Terminated
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 · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105483, Exp. Date 7/31/2024; - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105472, Exp. Date 4/30/2024; - Feb 7, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105551, Exp. Date 7/31/2024;
Product details
- Generic drug
- Buspirone: see every company that makes it
- Form
- tablet
- Strength
- 7.5 mg
- Approval
- ANDA ANDA202557
- On the market since
- Nov 14, 2016
- Package NDCs
50436-2010-1- Official label
- DailyMed (National Library of Medicine), updated Sep 20, 2019
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