Potassium Chloride Injection, Solution
FDA Recall NDC 0338-0709
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Potassium Chloride (NDC 0338-0709). A significant event, classified as Class II, was initiated on Nov 10, 2014 by Baxter Healthcare Corporation. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Nov 10, 2014
Dec 03, 2014
63,360 container bags
Recall Profile & Regulatory Data
Event ID
69518
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 03, 2016
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.
Batch or Lot Expiration Information
Lot# : P319160, Exp 06/30/15
Affected Packages Involved in this Recall
0338-0703-41Product
0338-0703-48Product
0338-0705-41Product
0338-0705-48Product
0338-0709-48Product
Class II Terminated
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Sep 08, 2014
Oct 01, 2014
148632 bags
Recall Profile & Regulatory Data
Event ID
69130
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 27, 2016
Product Description
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
Batch or Lot Expiration Information
Lot# Lot P318220, EXP 05/31/15
Affected Packages Involved in this Recall
0338-0703-41Product
0338-0703-48Product
0338-0705-41Product
0338-0705-48Product
0338-0709-48Product
Class I Terminated
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Jul 11, 2014
Sep 24, 2014
171,672 bags
Recall Profile & Regulatory Data
Event ID
68728
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Singapore, and Hong Kong
Termination Date
Sep 21, 2016
Product Description
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
Batch or Lot Expiration Information
Lot# : P309476, Exp 10/14
Affected Packages Involved in this Recall
0338-0703-41Product
0338-0703-48Product
0338-0705-41Product
0338-0705-48Product
0338-0709-48Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
