Drug product
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
D-303-2013
Product summary
- Event
- Event 64459
- Status
- Terminated
- Classification
- Class III
- Quantity
- 27,509 bottles
- Official record key
drug-enforcement:D-303-2013
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# 510122B; exp 04/13
Distribution pattern: US Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination