D-014-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2013
- Initiation Date
- September 4, 2013
- Termination Date
- April 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 bottles
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
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.
Distribution Pattern
US Nationwide
Code Information
Lot #: V121573, Exp 05/17