FDA recall D-1261-2014

Product

Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA

Reason for recall

Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-03-27

Report date

2014-04-30

Termination date

2015-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1261-2014