October 2013 FDA Recall Drug by Cardinal Health
D-0489-2015 - Labeling

This Class III drug recall was voluntarily initiated by Cardinal Health on October 2, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in OK and the recall is currently terminated.

Recall Number: D-0489-2015

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.
Initiated
10-02-2013
Reported
04-22-2015
Quantity
100 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70334
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cardinal Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OK
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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