Aldactone Tablet, Film Coated
FDA Recall NDC 0025-1041
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Aldactone (NDC 0025-1041). A significant event, classified as Class II, was initiated on Sep 04, 2013 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Sep 04, 2013
Nov 27, 2013
31 bottles
Recall Profile & Regulatory Data
Event ID
66124
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Us Pharmaceutical Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Apr 13, 2017
Product Description
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
0025-1001-31Product
0025-1041-31Product
0025-1031-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
