# FDA recall D-1096-2018

> **Northwind Pharmaceuticals LLC** · Class II · drug recall initiated 2018-07-18.

## Product

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Indiana

## Key facts

- **Recall number:** D-1096-2018
- **Recalling firm:** Northwind Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2018-08-22
- **Termination date:** 2023-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1096-2018

## Citation

> AI Analytics. FDA recall D-1096-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1096-2018. Source: US FDA. Licensed CC0.

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