FDA recall D-686-2013

Hospira Inc. · Class II · drug

Product

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.

Reason for recall

Presence of Particulate Matter: visible particles were identified floating in the primary container.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-02
Report date: 2013-07-17
Termination date: 2014-10-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-686-2013