CIPLA

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
11
Compliance Actions
0

Known Names

cipla, cipla limited

Recent Recalls

NumberClassProductDate
D-1550-2022Class IIArformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2September 29, 2022
D-1545-2022Class IIBudesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL SiSeptember 15, 2022
D-1499-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, MAugust 22, 2022
D-1498-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan PharmecuticaAugust 22, 2022
D-1328-2022Class IIDifluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, ManufactureAugust 2, 2022
D-1283-2022Class IIDifluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S InJuly 14, 2022
D-0660-2021Class IISolifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna,June 10, 2021
D-0182-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx oDecember 17, 2020
D-0181-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx oDecember 17, 2020
D-0183-2021Class IIEsomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx oDecember 17, 2020
D-0165-2021Class IIAzacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial ManDecember 14, 2020