# FDA recall D-0443-2016

> **Western Drug** · Class II · drug recall initiated 2015-10-19.

## Product

Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

## Key facts

- **Recall number:** D-0443-2016
- **Recalling firm:** Western Drug
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-19
- **Report date:** 2015-12-09
- **Termination date:** 2016-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Springerville, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2016

## Citation

> AI Analytics. FDA recall D-0443-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0443-2016. Source: US FDA. Licensed CC0.

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