FDA recall D-0020-2015

Product

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05

Reason for recall

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-29

Report date

2014-10-22

Termination date

2017-03-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2015