Drug 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.
D-304-2013
Product summary
- Event
- Event 64459
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,136 bottles
- Official record key
drug-enforcement:D-304-2013
Official wording
Reason: 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.
Code information: Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Distribution pattern: US Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination