Shilpa Medicare Limited

FDA Regulatory Profile

Shilpa Medicare Limited appears in FDA public data with 6 recalls, 0 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0124-2021, Class II) was initiated on December 8, 2020.

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0124-2021Class IIImatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare LimitedDecember 8, 2020
D-0125-2021Class IIImatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare LimitedDecember 8, 2020
D-0123-2021Class IIAzacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One SinglDecember 8, 2020
D-0122-2021Class IIAzacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One SinglDecember 8, 2020
D-0126-2021Class IIDocetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single UDecember 8, 2020
D-0121-2021Class IIBusulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use,December 8, 2020