The Recall Desk

FDA (Drugs) recall action 64459

Warner Chilcott Company LLC recalled 3 products on 2013-05-08

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-05-08
Critical
0
Units
51,053

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • LowFDA (Drugs)··2013-05-08

    Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

    Warner Chilcott is recalling 6,408 bottles of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

    Product
    Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-05-08

    Warner Chilcott Recalls Jevantique Tablets Due to Chemical Contamination

    Warner Chilcott is recalling Jevantique tablets because 2-phenylphenol was found in the product. The contamination resulted from migration from the cardboard cartons used for packaging.

    Product
    Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-05-08

    Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

    Warner Chilcott is recalling specific lots of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

    Product
    Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
    Category
    Distribution
    1 state