drugs Class II Updated 2013-11-27

Pfizer Us Pharmaceutical Group recalls Aldactone (spironolactone) tablets, USP, 100 mg, 100-count b

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: V121573, Exp 05/17
View official government recall

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