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Warner Chilcott Recalls
5 recalls on record · February 6, 2013 to May 8, 2013 · Drugs
May 8, 2013DrugsFDA
Warner Chilcott Company LLC recalls Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx
Hazard: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
May 8, 2013DrugsFDA
Warner Chilcott Company LLC recalls Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), R
Hazard: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
May 8, 2013DrugsFDA
Warner Chilcott Company LLC recalls Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx
Hazard: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
February 6, 2013DrugsFDA
Warner Chilcott Company LLC recalls Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hun
Hazard: Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
February 6, 2013DrugsFDA
Warner Chilcott Company LLC recalls Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt
Hazard: Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles