D-304-2013 Class III Terminated
FDA drug recall D-304-2013 was initiated by Warner Chilcott Company LLC on February 15, 2013 and is designated Class III. Reason for recall: 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 recall status is terminated (terminated June 9, 2014). Affected quantity: 17,136 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2013
- Initiation Date
- February 15, 2013
- Termination Date
- June 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,136 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide and Puerto Rico
Code Information
Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13