# FDA recall D-0469-2017

> **VistaPharm, Inc.** · Class II · drug recall initiated 2017-01-18.

## Product

Potassium Chloride Oral Solution,  USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL  33771.

## Reason for recall

Defective Container: Leakage of unit dose cups that may occur at the seal.

## Distribution

Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.

## Key facts

- **Recall number:** D-0469-2017
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-18
- **Report date:** 2017-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0469-2017

## Citation

> AI Analytics. FDA recall D-0469-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0469-2017. Source: US FDA. Licensed CC0.

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