FDAFDA · Food and drugs·Recall number D-304-2013
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.
Published May 8, 2013 · Recall initiated: February 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Warner Chilcott Company LLC
- Distributor
- US Nationwide and Puerto Rico
- Lot
- Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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