Cardinal Health recalls Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shi…

Recall date

October 2, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0489-2015

FDA classification

Class III

Brand / firm

Cardinal Health

Sold / distributed

OK

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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