May 2013 FDA Recall Drug by Warner Chilcott Us Llc
D-822-2013 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Warner Chilcott Us Llc on May 17, 2013 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-822-2013
Failed Impurities/Degradation Specifications: unspecified degradation product
05-17-2013
08-07-2013
188,600 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Warner Chilcott US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
11-30-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Batch or Lot Expiration Information
Lot# Lot F1002 - Exp.12/13
