Multi-event December 2012 FDA Recall Drug by Warner Chilcott Company Llc

This Multi-event Class III drug recall was voluntarily initiated by Warner Chilcott Company Llc on December 21, 2012 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specifications due to moisture ingress in individual bottles. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-141-12013 TERMINATED D-142-2013 TERMINATED

Recall Number: D-141-12013

Reason for Recall
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Initiated
12-21-2012
Reported
02-06-2013
Quantity
5439 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64014
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Warner Chilcott Company LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 0.9 mg: 512348A

Recall Number: D-142-2013

Reason for Recall
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Initiated
12-21-2012
Reported
02-06-2013
Quantity
3155 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64014
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Warner Chilcott Company LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2015
Product Description About Product Description
Full technical description of the product.
Femtrace 0.45 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

Batch or Lot Expiration Information

Lot# 0.45 mg: 505969A