Plasma-lyte A
Product Images NDC 0338-9591

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Plasma-lyte A (NDC 0338-9591). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Baxter Healthcare Company, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dhcp Letter 1 Of 17 (Image 01)

A letter dated November 6, 2024, from Baxter Healthcare Corporation addressing healthcare professionals about the temporary importation of several large-volume parenteral fluid products, including Plasma-Lyte A Injection from Alliston, Canada, due to drug shortages. The letter notes the FDA has not approved these products from Baxter's Alliston facility and emphasizes that only Baxter is authorized to import or distribute these products in the U.S. during this period.*

FDA Label Image

Dhcp Letter 2 Of 17 (Image 02)

A table listing Baxter Healthcare imported products with details including product name and description, size, product code, bags per carton, and NDC code of a single bag. It features 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer's Injection, and Plasma-Lyte A Injection in various sizes and packaging quantities.*

FDA Label Image

Dhcp Letter 3 Of 17 (Image 03)

This is a text panel highlighting important notes about imported pharmaceutical products related to Plasma-Lyte A and similar solutions. It discusses barcode formats, prescription status, compatibility warnings, and advises on product handling. The text also references multiple tables comparing FDA-approved and imported product labeling differences.*

FDA Label Image

Dhcp Letter 4 Of 17 (Image 04)

A text panel providing instructions for reporting adverse events or product quality issues related to imported products by Baxter Healthcare Company. It includes contact phone and fax numbers, FDA MedWatch reporting links and form download instructions, and a reference to Baxter's Product Feedback Portal for quality issues. The panel also lists links to FDA-approved prescribing information for three specific drug products: 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and Lactated Ringers Injection USP.*

FDA Label Image

Dhcp Letter 5 Of 17 (Image 05)

A letter related to Plasma-Lyte Injection, USP from Baxter Healthcare Corporation. The letter includes contact information for Baxter's Medical Information Service and Center for Service, a signature from Lee Ann Schuette, VP Global and US Marketing IV solutions, and mentions trademarks Baxter, Viaflex, and Plasma-Lyte. Attachments noted include Product Comparison Tables 1-8.*

FDA Label Image

Dhcp Letter 6 Of 17 (Image 06)

This data table compares FDA-approved and imported 0.9% Sodium Chloride Injection USP products, highlighting differences in label volume, language, indications, active ingredients, additional information, storage conditions, container type, and medication port closures. It includes images showing the medication and administration port closures with blue pull-off port protectors on the right side for both products.*

FDA Label Image

Dhcp Letter 7 Of 17 (Image 07)

A data table showing label images for FDA-approved and imported 0.9% Sodium Chloride Injection USP. It compares label designs for the same product from the US FDA and Alliston, Canada, including text layout, volume (1000 mL), and manufacturer details from Baxter Healthcare Corporation and Baxter Corporation respectively.*

FDA Label Image

Dhcp Letter 9 Of 17 (Image 08)

A data table titled 'Label images of FDA-approved and imported 5% Dextrose Injection USP' comparing US-FDA approved and imported products. It notes label color is black with 1000 mL shown as representative; barcodes and lot/expiration info are not shown on either label version.*

FDA Label Image

Dhcp Letter 9 Of 17 (Image 09)

A table comparing label images of FDA-approved and imported 5% Dextrose Injection USP. It notes that both US and imported products use black label color on 1000 mL representative labels, with no barcode or lot/expiration information shown for these labels.*

FDA Label Image

Dhcp Letter 10 Of 17 (Image 10)

Label for Plasma-Lyte A 5% Dextrose Injection USP, 1000 mL solution for injection. The label includes concentration details (5% Dextrose), osmolality (252 mOsmol/L), pH (4.0), and usage instructions for intravenous fluid and nutrient replenishment. The product is labeled by Baxter Healthcare Corporation, with units and lot/expiration fields visible.*

FDA Label Image

Dhcp Letter 11 Of 17 (Image 11)

FDA Label Image

Dhcp Letter 12 Of 17 (Image 12)

A data table comparing US FDA approved and imported Canadia versions of Lactated Ringer's Injection, USP. It details product names, label volumes, languages, indications, active ingredients per 100 mL, additional info, caloric content, storage conditions, container type (VIAFLEX PVC), and medication port closures with a small image of the port closure for each.*

FDA Label Image

Dhcp Letter 13 Of 17 (Image 13)

Label images of Lactated Ringer's Injection USP from US-FDA approved and imported Canadian products. The labels are black text on white background showing product name, volume 1000 mL, ingredients, usage instructions, and manufacturer Baxter Healthcare Corporation. The Canadian label includes lot number, DIN, and bilingual English and French text. Both indicate sterile injection for electrolyte replenishment.*

FDA Label Image

Dhcp Letter 14 Of 17 (Image 14)

Table titled 'Key differences between FDA-approved and imported Plasma-Lyte A Injection, USP' comparing characteristics of Plasma-Lyte A products. The table is from Baxter Healthcare documentation and appears on page 12 of 15 in a report.*

FDA Label Image

Dhcp Letter 15 Of 17 (Image 15)

A comparative data table detailing the US FDA approved and imported Canadian products for Plasma-Lyte A Injection, USP. It lists label volumes, label languages, indications, active ingredient concentrations per 100 mL, additional product information including pH and osmolarity, caloric content, storage conditions, and container type (VIAFLEX PVC).*

FDA Label Image

Dhcp Letter 16 Of 17 (Image 16)

Illustration showing administration port closures with medication and administration ports, each featuring a pull-off blue-colored port protector on the right side, related to Plasma-Lyte A packaging components by Baxter Healthcare Company.*

FDA Label Image

Dhcp Letter 17 Of 17 (Image 17)

Labels for Plasma-Lyte A Injection, USP, including a US FDA-approved label and an imported product label from Alliston, Canada. Both show the 1000 mL size. The US label indicates 7.4 pH with multiple electrolytes injection and includes the Baxter Healthcare logo and container details. The Canadian label includes electrolyte composition, instructions, and bilingual text with the Baxter logo and manufacturing location in Mississauga, ON.*

FDA Label Image

Container Label 0338-9591-01 (Image 18)

Plasma-Lyte A Injection label showing electrolyte concentrations including sodium, potassium, calcium, and acetate with pH 7.4. The product is an intravenous fluid and electrolyte replenishment solution supplied by Baxter Healthcare Company. The label includes directions for use, cautions, and container information, as well as brand name branding by Baxter Healthcare Corporation in Mississauga ON.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.