D-303-2013 Class III Terminated
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
- 27,509 bottles
Product Description
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
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# 510122B; exp 04/13