FDA recall D-0489-2015

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

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

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