FDA recall D-926-2013

Hospira, Inc. · Class II · drug

Product

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Reason for recall

Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Distribution

Naitonwide

Key facts

Status: Terminated
Initiation date: 2013-08-12
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-926-2013