FDA recall D-0004-2015

Product

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

Reason for recall

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Distribution

Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2014-09-29

Report date

2014-10-08

Termination date

2016-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2015