FDA-Drug2013-11-27Class II
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
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.
Sold states
US Nationwide
Affected count
31 bottles
Manufactured in
235 E 42nd St, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-014-2014Don't want to check this manually?
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