Warner Chilcott Company LLC

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-304-2013Class IIIJevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NFebruary 15, 2013
D-303-2013Class IIIFemhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#February 15, 2013
D-305-2013Class IIIFemhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#February 15, 2013
D-141-12013Class IIIFemtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics IntDecember 21, 2012
D-142-2013Class IIIFemtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics InDecember 21, 2012