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Ed K+10 FDA Alerts

The FDA Alerts below may be specifically about Ed K+10 or relate to a group or class of drugs which include Ed K+10.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Ed K+10

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch

Nov 21, 2014 | Audience: Pharmacy, Nursing, Consumers

ISSUE: Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL.

The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population – patients prone to severe electrolyte imbalance – this hazardous situation may lead to serious, life-threatening adverse health consequences. There have been no reported adverse events associated with this issue to date.

BACKGROUND: Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Products were distributed to customers in the U.S. between June 23, 2014 and October 2, 2014.

RECOMMENDATION: Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lot numbers can continue to be used according to the instructions for use. Unaffected lots of product are available for replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[11/20/2014 - Press Release - Baxter International Inc]

Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling

Sep 17, 2014 | Audience: Pharmacy, Risk Manager, Nursing

ISSUE: Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.

As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. There have been no reported adverse events associated with this situation to date.

BACKGROUND: Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for intravenous administration.

RECOMMENDATION: It is recommended that healthcare professionals carefully review the product label before administering.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[09/16/2014 - Firm Press Release - Baxter International, Inc]