# FDA recall D-010-2014

> **Greenstone Llc** · Class II · drug recall initiated 2013-09-04.

## 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

- **Recall number:** D-010-2014
- **Recalling firm:** Greenstone Llc
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-010-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-010-2014. Source: US FDA. Licensed CC0.

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