Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only,...
FDA Recall #D-0370-2024 — Class II — March 6, 2024
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
Reason for Recall
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.
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
22,752 bags
Distribution
Nationwide in the USA
Code Information
Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated