Plasma-lyte A Injection, Solution
Product Images NDC 0338-9591

This is a notification from Baxter Healthcare Corporation regarding the temporary importation of critical drug products to address shortages. The products include 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer's Injection, and PlasmarLyte A Injection from Alliston, Canada. Healthcare professionals are advised to review the information provided in detail to understand the specific product-related details. It is highlighted that Baxter is the only authorized entity by the FDA for the importation and distribution of these products in the United States.*

This document provides information on the imported medical products currently offered by Baxter during a temporary period. The list includes products such as 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer's Injection, and PlasmaLyte A Injection, each available in various sizes and packaging configurations. The document also references a specific NDC code for the products listed.*

This text provides important information regarding imported medical products with a 2D barcode, including the GTIN, lot number, and expiration date. It highlights the need for careful verification of product identification due to potential issues with U.S. scanning systems. It also emphasizes the necessity of following correct procedures for product administration to patients. Additionally, it mentions specific incompatibilities between certain products and provides guidance on addressing visible particulates or leaks in IV bags. The document includes tables comparing FDA-approved products with imported versions for Sodium Chloride Injection, Dextrose Injection, Lactated Ringer's Injection, and PlasmarLyte A Injection, showcasing key differences in labeling and visuals.*

This text provides instructions on how to report adverse events or product quality issues related to imported products. It includes contact information for Baxter and the FDA's MedWatch Adverse Event Reporting program. Additionally, it references specific drug products and FDA-approved prescribing information. To report product quality issues, individuals are directed to contact Baxter through the Product Feedback Portal.*

This document provides a detailed comparison between FDA-approved and imported 0.9% Sodium Chloride Injection USP. It outlines key differences such as product name, label volumes available, languages on the label, indications, active ingredients, additional information like pH and osmolarity, storage conditions, container types, and medication administration details. The comparison sheds light on various aspects that may influence the choice between the approved and imported versions of the product for medical use.*

This text appears to be a description of different label images of 0.9% Sodium Chloride Injecton USP products. The labels are from both US-FDA approved product and an imported product from Aliston, Canada. The labels specify the product name, Lobel Color, and the product volume. It also mentions that the Barcode, lot number, and expiration date are not shown in the labeled images. Additionally, the text references the product name in different formats such as "055 Sodm Chiorde imecion, ISP" and "JB1324 1000 mL N o0os0z08 1". The last line mentions "SHITT-CADHCP 202410021, Rev 00" and "Pagesof1s" without clear context.*

The text describes tabled label images of FDA-approved and imported 5% Dextrose Injection USP. The comparison is made between an FDA-approved product and an imported product from Allston, Canada. The label color for both products is shown as black for a 1000 mL container, with a barcode, lot number, and expiration date not shown. This document appears to be part of a regulatory or quality control process for healthcare products.*

The text provides information about FDA-approved 5% Dextrose Injection USP. It mentions that the product is imported from Allston, Canada. It compares the label colors and indicates that 1000 mL is shown as a representative label for both FDA-approved and imported products. However, it states that the barcode, lot number, and expiration date are not shown in the provided content. This information is part of document SHTT-CADHCP 202410021, Revision 00.*

This is a 1000 mL bag of 5% Dextrose Injection USP manufactured by Baxter. It contains 5% Dextrose solution suitable for injection. The bag is labeled with the code JB0064, DIN 00060348. The solution is also known as D5W and each bag contains approximately 252 mOsmol/L with a pH of 4.0. The product appears to be Dextrose Hydrate USP. The reference code on the label is SHTT-CA-DHCP-202410.021, Rev 00.*

This is a description of an FDA-approved imported product, Lactated Ringer's Injection, USP. The product is available in various volumes ranging from 250 mL to 1000 mL. It contains active ingredients like Sodium Chloride, Sodium Lactate, Potassium Chloride, and Magnesium Chloride, which provide a source of water, electrolytes, and can act as an alkalizing agent. The product has specific indications for use, and each 100 mL contains a specified amount of the active ingredients. It is important to store the product at room temperature. The packaging comes in ViarLex containers with medication and administration ports.*

The text is not readable.*

This text provides a comparison between FDA-approved and imported Plasma-Lyte A Injection, USP. It may offer insights into the key differences between the two products. The document seems to be a part of a larger document titled SHTT-CA-DHCP, with a reference number of 202410021, Revision 00, on page 120115.*

This is a US FDA approved product imported from Alkston, Canada. The product comes in various strengths and formulations, suitable for different indications. It is recommended for use by healthcare professionals and is compatible with both oral and blood-based measurements. The product is labeled with information such as the active ingredients, dosage strengths, and recommended storage conditions.*

This appears to be a medical document discussing the administration and port closures for a certain medical device. The document seems to reference medication ports and administration ports, as well as a "pull-off" port. The document likely includes instructions or guidelines for using the device.*

This text contains information about two different products labeled as FDA-approved Plasma-Lyte A Injection, USP, one being a US-FDA approved product and the other an imported product from Alliston, Canada. It includes details such as label color, presence of barcode, lot number, and expiration date. The products are described as having a pH of 7.4 with specific electrolyte concentrations. The labels are black, and important information such as lot number and expiration date are provided for one product but not the other. The text also mentions the manufacturer, Baxter Corporation, located in Mississauga, ON.*

This is a description for an intravenous solution called PLASMA-LYTE A, used for fluid and electrolyte replenishment. Each 100 mL contains sodium chloride, sodium gluconate, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, and water for injection. The solution is adjusted to a pH of 7.4 using sodium hydroxide. It comes in a VIAFLEX PVC container and is nonpyrogenic, sterile, and for single use only. The product should be discarded if unused, and caution is advised to not use in series connections. STore the solution at temperatures between 15 and 25 degrees Celsius. Trademarks for PLASMA-LYTE A and VIAFLEX belong to Baxter International Inc.*