Home / Recalls / Warner Chilcott Company LLC / D-141-12013

D-141-12013 Class III Terminated

Recalled by Warner Chilcott Company LLC — Fajardo, PR

Recall Details

Product Type
Drugs
Report Date
February 6, 2013
Initiation Date
December 21, 2012
Termination Date
June 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5439 bottles

Product Description

Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

Reason for Recall

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Distribution Pattern

US Nationwide

Code Information

0.9 mg: 512348A

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-305-2013 Class III — Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 (February 15, 2013)
  • D-142-2013 Class III — Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured (December 21, 2012)