FDA recall D-0391-2015

Product

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

Reason for recall

Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-10-16

Report date

2015-02-25

Termination date

2015-12-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2015