FDA recall D-309-2013

Product

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-08-28

Report date

2013-05-08

Termination date

2014-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-309-2013