Pfizer Us Pharmaceutical Group recalls Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfi
Recalled November 27, 2013 · FDA recall D-014-2014 · Pfizer Us Pharmaceutical Group
Hazard
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. · FDA Class II
Units
31 bottles
Sold at
US Nationwide
Description
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.
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
Manufacturer(s)
Pfizer Us Pharmaceutical Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →