FDA recall D-0865-2016

Hospira Inc. · Class I · drug

Product

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Reason for recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2016-03-18
Report date
2016-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2016