Padagis US LLC

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0246-2025Class IIEstradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured bFebruary 6, 2025
D-0048-2025Class IIITriamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, MOctober 11, 2024
D-0139-2024Class IITrospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured ByNovember 1, 2023
D-0081-2024Class IIGynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, paSeptember 28, 2023
D-0464-2023Class IIIEvamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per meterFebruary 21, 2023
D-1497-2022Class IITriamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 1045August 17, 2022
D-0372-2022Class IINitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, ManufactuDecember 27, 2021