Key Takeaway

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 55 by Cardinal Health was recalled on October 2, 2013. The hazard: Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chlori...

FDA Drug Class III Terminated

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 55

Recalled: October 2, 2013 ~100 blister cards units affected D-0489-2015

Description

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

Hazard / 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.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Drugs

Distribution

Related Recalls

FDA Food Class II

Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4

November 13, 2012

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.