PlainRecalls
FDA Drug Moderate Class II Terminated

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

Reported: December 3, 2014 Initiated: November 10, 2014 #D-0256-2015

Product Description

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

Reason for Recall

Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
63,360 container bags
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.. Recalled by Baxter Healthcare Corp.. Units affected: 63,360 container bags.
Why was this product recalled?
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 3, 2014. Severity: Moderate. Recall number: D-0256-2015.