Warner Chilcott Company LLC

FDA Regulatory Profile

Warner Chilcott Company LLC appears in FDA public data with 5 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-303-2013, Class III) was initiated on February 15, 2013.

Summary

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

Recent Recalls

NumberClassProductDate
D-303-2013Class IIIFemhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#February 15, 2013
D-304-2013Class IIIJevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NFebruary 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