FDA Drug recall D-0489-2015
Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manuf…
- FDA Drug
- Class III
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class III recall of Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manuf… by Cardinal Health, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0489-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-02 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cardinal Health |
| Distribution | OK |
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
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.
Identifiers
| code_info | Lot #: 315004A, Exp 1/15/14; Lot #: 315620A, Exp 1/15/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.