Greenstone Llc recalls Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59
Recalled November 27, 2013 · FDA recall D-010-2014 · Greenstone
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
2796 bottles
Sold at
Nationwide and Puerto Rico
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
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
Manufacturer(s)
Greenstone Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →