Home / Recalls / Warner Chilcott Company LLC / D-305-2013

D-305-2013 Class III Terminated

Recalled by Warner Chilcott Company LLC — Fajardo, PR

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
6,408 bottles

Product Description

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), 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# 507694B; exp 02/13

Other recalls by Warner Chilcott Company LLC

  • D-304-2013 Class III — Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg (February 15, 2013)
  • D-303-2013 Class III — Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 9 (February 15, 2013)
  • D-141-12013 Class III — Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured (December 21, 2012)
  • D-142-2013 Class III — Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured (December 21, 2012)