Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Oct 25, 2021 · Class II · Sun Pharmaceutical Industries Inc
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Lots: Lot # DNC1127A, exp. date 05/2023 - Oct 25, 2021 · Class II · Sun Pharmaceutical Industries Inc
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Lots: Lot # DNC0814A, DNC0815A, Exp. Date 04/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tadalafil: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA208934
- On the market since
- Feb 19, 2020
- Package NDCs
16714-075-01- Official label
- DailyMed (National Library of Medicine), updated Nov 10, 2023
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