FDA recall D-0972-2015

Hospira Inc. · Class II · drug

Product

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49

Reason for recall

Crystallization

Distribution

Nationwide, Puerto Rico and Guam.

Key facts

Status: Terminated
Initiation date: 2015-04-13
Report date: 2015-05-06
Termination date: 2017-12-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0972-2015