FDA recall D-1486-2019

Product

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.

Reason for recall

Lack of Assurance of Sterility: Bags have the potential to leak.

Distribution

United States, PR, and Guam

Key facts

Status

Terminated

Initiation date

2019-07-09

Report date

2019-07-24

Termination date

2021-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1486-2019