Lactated Ringers
Product Images NDC 0338-9596

This is a notification from Baxter Healthcare Corporation regarding the temporary importation of essential drug products from Canada to address potential shortages in the United States. The products include Sodium Chloride Injection, Dextrose Injection, Lactated Ringer's Injection, and PlasmaLyte A Injection. Healthcare professionals are advised to review the information provided in its entirety, as each product may have specific details. Baxter is the only authorized entity by the FDA for this importation.*

This text provides important information about imported medical products, focusing on differences in labeling, barcoding, and usage compared to FDA-approved products in the U.S. It emphasizes the need for correct identification and administration processes to ensure patient safety. The text mentions specific products like Sodium Chloride Injection, Dextrose Injection, and Lactated Ringer's Injection, highlighting key distinctions and precautions to be taken while using them. Additionally, it points out incompatibilities with specific products like Baxter's Vial-mate. It includes tables comparing the FDA-approved products and imported versions, specifying differences in labeling and providing label images for comparison. Overall, this text serves as a useful guide for healthcare professionals dealing with these imported medical products.*

This text provides information on how to report adverse events or product quality issues related to imported products from Baxter. Adverse events can be reported by calling Baxter at 1-866-888-2472 or faxing at 1-800-759-1801. Alternatively, reports can be submitted to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax. Product quality issues can be reported through Baxter's Product Feedback Portal. Additionally, the text references FDA-approved prescribing information for specific drug products, such as 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, and Lactated Ringers Injection, USP.*

This is a comparison table between FDA-approved and imported 0.9% Sodium Chloride Injection USP. It includes key differences such as label volumes, language of labeling, indications, active ingredients, additional information, storage conditions, container type, and administration port closures. It can help in understanding the variations between the two products for better decision-making.*

This text provides a comparison between label images of a 0.9% Sodium Chloride Injection USP product approved for use in the US and an imported product from Aliston, Canada. The labels indicate the black color of the product, the volume (1000 mL), and mention that they are representative labels. However, crucial information like the barcode, lot number, and expiration date are not visible in the provided text. The labels also display the names of the products in both English and French. The document seems to end with a reference to a specific SHITT-CADHCP code and mentions that it is one page in length.*

This text appears to be a detailed description of two types of Dextrose Injection solutions - Dextrose Injection, USP and 5% Dextrose Injection, USP. It includes information on their indications as a source of water and calories, active ingredients, osmolarity, caloric content, storage conditions, and container type. The text outlines differences between the two solutions in terms of their formulation and concentrations. Additionally, it mentions the manufacturer's information and product code.*

This text provides information about FDA-approved and imported 5% Dextrose Injection USP. It mentions the differences between the FDA-approved product and the imported product from Allston, Canada. Details such as label color, size (1000 mL), and the absence of the barcode, lot number, and expiration date are highlighted. The text seems to be part of labeling information or product specifications.*

This is a description of a 1000 mL bag of 5% Dextrose Injection USP by Baxter. The solution is commonly referred to as D5W and each bag contains approximately 252 mOsmol and has a pH of around 4. This sterile solution is suitable for injection as it contains USP grade Dextrose at a 5% concentration. The product is labeled with JB0064, DIN 00060348, and it is identifed as a 100 Dextrose Hydrate USP solution. Additionally, the product reference is SHTT-CA-DHCP-202410.021, Rev 00.*

Not available.*

This is information about an FDA approved product called Lactated Ringer's Injection, sourced from Allston, Canada. It comes in various volumes and is available in English and French. The product is used as a source of water, electrolytes, or as an alkalinizing agent. Its ingredients include Sodium Chloride, Sodium Lactate, Potassium Chloride, and Magnesium Chloride. The product is stored at room temperature. It contains medication and administration ports.*

This text describes label images of FDA-approved and imported Lactated Ringer's solution in 1000 mL packaging. The labels include information about the product origin and composition, such as sodium, potassium, calcium, lactate concentration, and other components. The text mentions color, barcode absence, and representation of the label with specific details like DIN number and expiration date. Additionally, it includes a reference to Injection USP and Injectable Lactated Ringer's solution with specific composition details.*

This text mentions a comparison table showing the key differences between FDA-approved and imported Plasma-Lyte A Injection, USP. It seems to be part of a document with reference code SHTT-CA-DHCP 202410021, Rev 00 on page 120115.*

This text appears to be a description of a medical device with medication and administration ports. It seems to mention port closures and different types of ports such as medication, administration, and pull-off ports. The document may also refer to a specific part number or reference code: SHTT-CADHCP 202410021, Rev 00.*

This document provides information comparing FDA-approved and imported Plasma-Lyte A Injection, USP. It includes details about label colors, the absence of barcodes on the imported product, and electrolyte content in the solution. It also mentions the manufacturer, Baxter Corporation, based in Alliston, Canada.*

This text is a detailed description of a medical product labeled as Lactated Ringer's Injection. It provides information on the composition of the injection, electrolyte concentrations, instructions for use, storage conditions, and cautions. It also mentions that the product is a non-pyrogenic sterile solution stored in a VIAFLEX PVC container. The text includes instructions in English and French, along with trademarks from Baxter International Inc. It seems to be a pharmaceutical product information leaflet or label.*