Product Images Sodium Chloride 0.9%

This text provides details about SLHFRZ-1000ml Sodium Chloride Injection, including its size, components, approval number, specifications, indications, dosage, precautions, storage instructions, manufacturer information, batch number, manufacturing date, and expiration date. The product is described as a non-PVC co-extruded film in a double hard tube with double valves and plugs, suitable for regulating water and electrolyte balance intravenously. Consumers are advised to check for leaks, clarity of the liquid, and visible particles before use. The product is authorized for marketing by Huaren Pharmaceutical Co., Ltd.*

This document outlines the temporary importation of 0.9% Sodium Chloride Injection products from Shandong Province, China, by Smith Associates to address drug shortages in the United States. The imported products are from HUAREN PHARMACEUTICAL CO., LTD and are not approved by the FDA. Healthcare providers are advised to follow specific procedures to ensure the correct product is used, and caution is advised regarding barcode systems. The imported products lack the "Rx only" statement on labeling, and a new container should be used if particulates are visible or if the IV container has a leak.*

This is a letter containing important information comparing FDA-approved Sodium Chloride Injection with imported products. It includes tables showing key differences, label images, and guidance for reporting adverse events associated with the product. Contact details for reporting adverse events and placing orders with Smith Associates are provided. Healthcare providers are encouraged to review the information and ensure proper administration of the product.*

This text is a signature and contact information for Smith Associates. The company's email is [email protected] and their phone number is 888-729-9674 extension 203. The document mentions that a letter will require the manufacturer's signature along with the recipient's signature, email, and phone contact information. It also indicates that this information will be included in an amendment to the FDA.*