Potassium Chloride — Class III drug recall D-0489-2015
Terminated recall by Cardinal Health, reported 2015-04-22, distributed in OK. Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq
| Recall number | D-0489-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Zanesville, OH, United States |
| Recall initiated | 2013-10-02 |
| Classified | 2015-04-15 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-09-30 |
| Distributed | OK |
| Quantity | 100 blister |
| Reason classes | labeling, potency |
| Lot numbers | 315004A, 315620A |
| Expiration dates | 2014-01-15 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0489-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.