Milrinone Lactate Injection 200 mcg /mL* in 5% Dextrose Injection recalled over sterility concerns

Recall date

July 9, 2019

Source

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

Official notice title

Pfizer Inc. recalls Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira,…

Recall number

D-1487-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

United States, PR, and Guam

Why it was recalled

Lack of Assurance of Sterility: Bags have 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

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.