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Recall Observatory FDA recall evidence

Drug 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

D-0489-2015

October 02, 2013

Class III

Product summary

Firm
Cardinal Health
Event
Event 70334
Status
Terminated
Classification
Class III
Quantity
100 blister cards
Official record key
drug-enforcement:D-0489-2015

Official wording

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.

Code information: Lot #: 315004A, Exp 1/15/14; Lot #: 315620A, Exp 1/15/14

Distribution pattern: OK

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing