Shilpa Medicare Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0121-2021 | Class II | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, | December 8, 2020 |
| D-0125-2021 | Class II | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited | December 8, 2020 |
| D-0126-2021 | Class II | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single U | December 8, 2020 |
| D-0123-2021 | Class II | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Singl | December 8, 2020 |
| D-0124-2021 | Class II | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited | December 8, 2020 |
| D-0122-2021 | Class II | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Singl | December 8, 2020 |