September 2013 FDA Recall Aldactone by Pfizer Us Pharmaceutical Group
D-014-2014 - Marketed without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Pfizer Us Pharmaceutical Group on September 4, 2013 for the product Aldactone. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-014-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Initiated
09-04-2013
Reported
11-27-2013
Quantity
31 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66124
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Us Pharmaceutical Group
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.
04-13-2017
Product Description About Product Description
Full technical description of the product.
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31

Batch or Lot Expiration Information

Lot# : V121573, Exp 05/17

Affected Packages Involved in this Recall

0025-1001-31 Aldactone
0025-1041-31 Aldactone
0025-1031-31 Aldactone