Status
Terminated
Drug Enforcement D-304-2013
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.
Classification
Class III
Report Date
May 8, 2013
Termination Date
June 9, 2014
Product Information
- 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.
- Product quantity
- 17,136 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Warner Chilcott Company LLC
- Address
-
Road 195, Km 1.1, Union Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-304-2013
- Event ID
- 64459
- Recall initiation date
- February 15, 2013
- Center classification date
- April 30, 2013
- Code info
- Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
- More code info
- —