FDA recall D-0483-2015

Hospira Inc. · Class II · drug

Product

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Reason for recall

Crystallization

Distribution

U.S. Nationwide and International: Guam and Singapore.

Key facts

Status: Terminated
Initiation date: 2015-01-23
Report date: 2015-04-15
Termination date: 2016-02-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2015