Sodium Chloride Injection, Solution
Product Images NDC 0338-9808

This text provides important prescribing information from Baxter Healthcare Corporation regarding the temporary importation of various parenteral solutions manufactured in Shanghai, China. The imported products include 0.9% Sodium Chloride Injection, 5% and 10% Glucose Injection, and 5% Glucose/0.9% Sodium Chloride Injection. The letter emphasizes the need for visual inspection of the bags to ensure there is no particulate matter or defects, to maintain container integrity for product sterility. It specifies the product names, sizes, and product codes for each item being imported. Baxter is working with the FDA to address potential drug shortages through this temporary importation.*

This text provides detailed information about the differences between imported medical products and their counterparts approved in the United States. It covers issues like barcode discrepancies, compatibility with other products, hydration forms, and labeling distinctions. It also highlights the importance of adjusting protocols and systems for accurate medication administration. Additionally, it emphasizes the need for prescription for certain products and mentions specific tables with key differences and label images for comparison. Overall, it offers essential insights for healthcare professionals dealing with imported medical products.*

This text provides information on how to report adverse events or product quality issues related to imported products. It includes contact information for Baxter, the FDA's MedWatch Adverse Event Reporting program, and a portal for reporting product quality issues. It also mentions the availability of prescribing information for various drug products and provides contact details for inquiries and placing orders with Baxter.*

The provided text appears to be a description of FDA-approved and imported 0.9% Sodium Chloride Injection USP products that are being evaluated. The information includes details such as the label design, label color, brand names (Baxter), and mention of the NDC number present in the imported product. The text mentions that the imported product contains a linear barcode with human-readable information, implying an advanced tracking system. The evaluation also refers to the origins of the imported product from Shanghai, China. Overall, the text provides insights into the labeling and packaging of these medical products for assessment purposes.*

This text compares the key differences between FDA-approved 5% Dextrose Injection USP and imported 5% Glucose Injection. The differences highlighted include the product name, label volumes, indications, active ingredients, additional information such as osmolarity, caloric content, storage conditions, container type, and medication and administration port closures. The comparison covers various aspects that are important for differentiating between the two products.*

This is a comparison between FDA-approved 10% Dextrose Injection USP and imported 10% Glucose Injection from Shanghai, China. The key differences include product name, label volume, language on labels, indication as a source of water and calories, active ingredients, osmolarity, caloric content, storage instructions, container type, and administration components. This information can help in understanding the differences between these two products and their suitability for various medical purposes.*

This text describes key differences between FDA-approved 5% Dextrose/0.9% Sodium Chloride Injection USP and imported 5% Glucose/0.9% Sodium Chloride Injection. It compares the product names, labels, languages mentioned, indications, ingredients, osmolarity, storage conditions, and administration ports for both products.*

This text provides information about a Baxter® A6C1322US Sodium Chloride Injection in a 250ml size. It includes details such as the strength, dosage, administration instructions, storage recommendations, and the license number. Additionally, it mentions the drug marketing authorization holder and manufacturer as Baver Healthcare (Shanghai) Co. Ltd. The text also includes a lot number, manufacturing details, and expiry date.*

Product Name: Baxter A6C1324US Sodium Chloride Injection 1000ml Description: This product is a sterile, colorless liquid for intravenous use. Refer to the package insert for dosage and administration instructions. Storage: Store in overwrap. Important: The solution should be clear and should be used immediately after opening. Do not squeeze the bag and discard if the solution is not clear. Manufacturer: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai GTIN Barcode available. Refer to packaging for details on Indications, Adverse Reactions, Contraindications, and Precautions.*