10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection recalled over sterility concerns

Recall date

October 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Fores…

Recall number

D-0136-2020

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the United States and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: Bag has the potential to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13