FDA recall D-1815-2015

Product

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

Reason for recall

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2015-08-25

Report date

2015-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1815-2015