Plasma-lyte 148 (ph 7.4) Injection, Solution
Product Images NDC 0338-9593

This is a notice from Baxter Healthcare Corporation regarding the temporary importation of Plasma-Lyte 148 (pH7.4) Solution for Infusion from Sabifénigo, Spain to address drug shortages. Baxter is coordinating with the FDA for this temporary measure. The notice provides information about the product, its size (1,000mL), and product code (GCCE052a.10). Healthcare professionals are advised to visually inspect the bags for any defects before administration. It mentions that only Baxter is authorized to import and distribute this product in the United States during this period.*

The imported product may not have a barcode on its label, requiring institutions to manually input the product into their systems. It is essential to take appropriate precautions to ensure accurate product identification and to follow alternative procedures for proper drug product and concentration usage. The FDA-approved product Plasma-Lyte A Injection pH 7.4 is available in the United States by prescription and has certain differences in labeling compared to the imported product. Further details and comparisons can be found in the provided tables. For reporting adverse events or product quality issues related to the imported product, contact Baxter directly or report to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax. Baxter's Medical Information Service is also available for any inquiries regarding the imported product or this communication.*

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The text provides a comparison of FDA-approved Plasma-Lyte A Injection with imported Plasma-Lyte 148 Solution for Infusion from Spain. It outlines key differences in ingredients, indications, and container types between the two products. Plasma-Lyte A Injection pH 7.4 is indicated as a source of water and electrolytes, an alkalizing agent, for fluid replacement in various clinical conditions, and compatibility with blood transfusions. It contains ingredients like sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride, among others. The text also mentions storage instructions and the container types for each product.*

This is a description of a product which is FDA-approved and imported from Spain. It appears to be a medication product with administration ports, pull off port protector, and port closures. The text seems to contain instructions or information related to the use of this medication product.*

This text provides a comparison between FDA-approved PlasmaLyte A pH 7.4 and imported Plasma-Lyte 148 (pH 7.4) Solution for Infusion. It mentions label colors, origin information, and missing details such as barcode, lot number, and expiration date. PlasmaLyte A Injection pH 7.4 is identified as a multiple electrolyte injection type 1 USP in a 1000 mL Baxter container. The imported Plasma-Lyte 148 solution is also indicated with a pH of 7.4. The text gives insight into the products' characteristics and labeling.*