June 2014 FDA Recall Drug by Pfizer Inc.
D-1485-2014 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Pfizer Inc. on June 19, 2014 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-1485-2014

Reason for Recall
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Initiated
06-19-2014
Reported
08-06-2014
Quantity
22,461 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68639
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.
Pfizer Inc.
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.
Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-03-2015
Product Description About Product Description
Full technical description of the product.
Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30

Batch or Lot Expiration Information

Lot# V130822; Exp 01/15