# FDA recall D-341-2014

> **Sandoz Inc** · Class III · drug recall initiated 2013-11-06.

## Product

Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05

## Reason for recall

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-341-2014
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-06
- **Report date:** 2013-12-18
- **Termination date:** 2014-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilson, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-341-2014

## Citation

> AI Analytics. FDA recall D-341-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-341-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*