Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.
NDC 50436-0089
Finasteride 1 mg tablet, film coated
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Accord Healthcare Inc.'s NDC 16729-089.
Where the pills inside were made
Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.
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: a) P2005979, Exp. Date 10/31/2023; P2100252, Exp. Date 12/31/2023; P2101710, Exp. Date 2/29/2024; b) P2100253, Exp. Date 12/31/2023; P2103035, Exp. Date 4/30/2024; P2103036, Exp. Date 4/30/2024;
Product details
- Generic drug
- Finasteride: see every company that makes it
- Form
- tablet, film coated
- Strength
- 1 mg
- Approval
- ANDA ANDA091643
- On the market since
- Nov 8, 2013
- Package NDCs
50436-0089-150436-0089-3- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2019
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