FDA recall D-927-2013

Product

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

Reason for recall

Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-08-16

Report date

2013-09-04

Termination date

2014-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-927-2013