FDA recall D-099-2013

Hospira, Inc. · Class II · drug

Product

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

Reason for recall

Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-10-04
Report date: 2012-12-26
Termination date: 2014-05-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-099-2013