FDA recall D-010-2014

Product

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

Reason for recall

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-09-04

Report date

2013-11-27

Termination date

2017-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peapack, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-010-2014