# FDA recall D-0489-2015

> **Cardinal Health** · Class III · drug recall initiated 2013-10-02.

## Product

Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701

## Reason for recall

Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.

## Distribution

OK

## Key facts

- **Recall number:** D-0489-2015
- **Recalling firm:** Cardinal Health
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-02
- **Report date:** 2015-04-22
- **Termination date:** 2015-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zanesville, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2015

## Citation

> AI Analytics. FDA recall D-0489-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0489-2015. Source: US FDA. Licensed CC0.

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