# FDA recall D-393-2014

> **Sandoz Inc** · Class II · drug recall initiated 2013-10-11.

## Product

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

## Reason for recall

Subpotent; Hydrochlorothiazide at the 9 month time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-393-2014
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-11
- **Report date:** 2014-01-08
- **Termination date:** 2015-03-05

- **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-393-2014

## Citation

> AI Analytics. FDA recall D-393-2014. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-393-2014. Source: US FDA. Licensed CC0.

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