0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525...
FDA Recall #D-407-2014 — Class II — November 27, 2013
Product Description
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
Reason for Recall
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
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
19,572 bags
Distribution
Nationwide in the US and Puerto Rico.
Code Information
Lot No. J3D548, expiry: Oct, 2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated