drugs Class II Updated 2013-11-27

Greenstone Llc recalls Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle

Recalled Product

Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.

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 #: V121207, V121208, Exp 03/31/2017
View official government recall

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