0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Summary
The FDA issued a Class III for 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Br by B. Braun Medical Inc.. Reason: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed..
Details
Source
Drug Recall
External ID
D-1083-2023
Action Date
2023-08-16
Status
Terminated
Category
drug
Product Description
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Lot/Code Info: Lot #: 0061852531, Exp 2/28/2025
Quantity Affected: 43,812 bags
Reason for Recall
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Distribution
United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-02
Company
Daytona Beach, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 165 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
B. Braun Medical Inc. has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B. Braun Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B. Braun Medical Inc. have FDA actions?
B. Braun Medical Inc. has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1083-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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