Potassium Chloride Injection, Solution, Concentrate
FDA Recall NDC 0264-1944
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Potassium Chloride (NDC 0264-1944). A significant event, classified as Class II, was initiated on Mar 06, 2024 by B. Braun Medical Inc.. The reported reason for this action was: "Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks."
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
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Mar 06, 2024
Mar 20, 2024
22,752 bags
Recall Profile & Regulatory Data
Event ID
94184
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 16, 2025
Product Description
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Batch or Lot Expiration Information
Lot# : J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Affected Packages Involved in this Recall
0264-1944-20Product
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.
