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  4. Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025
  1. Safety & Availability (Biologics)

Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025

This is to provide you with important information regarding 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) manufactured by Hospira Inc., a Pfizer company.

Based upon FDA’s evaluation of stability data, FDA has extended the expiration date on one lot of 10% LMD in 0.9% Sodium Chloride Injection (lot # 5859955) and one lot of 10% LMD in 5% Dextrose Injection (lot # 6040410) as follows:

Lot Number Original Expiry Date New Expiry Date
5859955 April 1, 2024 April 1, 2024 – April 1, 2025
6040410 November 1, 2024 November 1, 2024 – September 1, 2025

The FDA is not requiring or recommending that the lots identified above be relabeled with new expiration dates. If you have bags of lot #5859955 in your current inventory, labeled with an expiration date of April 1, 2024, you may continue to maintain the product in your inventory and keep it available for use until April 1, 2025. If you have bags of lot #6040410 in your current inventory, labeled with an expiration date of November 1, 2024, you may continue to maintain the product in your inventory and keep it available for use until September 1, 2025.

Please use available inventory on a first-in, first-out basis through the new expiration dates as noted above.

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