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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

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.
Recall Number D-407-2014
Classification Class II
Code Info Lot No. J3D548, expiry: Oct, 2015
Product Distributed Qty 19,572 bags
Reason For Recall Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).

Event Detail

Event Id 67095
Product Type Drugs
Status Ongoing
Recalling Firm B. Braun Medical Inc
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide in the US and Puerto Rico.