FDA recall D-1278-2014

Hospira Inc. · Class I · drug

Product

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.

Reason for recall

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-12-23
Report date
2014-05-07
Termination date
2014-10-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1278-2014