Medisca Inc.

FDA Regulatory Profile

Summary

Total Recalls
10 (2 Class I)
510(k) Clearances
0
Inspections
20
Compliance Actions
1

Known Names

medisca, medisca inc

Recent Recalls

NumberClassProductDate
D-0386-2025Class IIBimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDMarch 31, 2025
D-0570-2024Class IIBudesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc.,June 26, 2024
D-0622-2020Class IIEstriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., PNovember 25, 2019
D-1174-2017Class IIAminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 gSeptember 14, 2017
D-0664-2017Class IIESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDCApril 3, 2017
D-0665-2017Class IIESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-0April 3, 2017
D-0666-2017Class IIESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) April 3, 2017
D-0663-2017Class IIESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) ,April 3, 2017
D-0674-2016Class ICITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder,February 14, 2014
D-1263-2014Class IHuman Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution inOctober 21, 2013