FDA recall D-1241-2015

Product

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Reason for recall

Crystallization; identified as calcium salt of Ketorolac

Distribution

Nationwide, Puerto Rico, Guam, Canada and Singapore

Key facts

Status

Ongoing

Initiation date

2015-06-30

Report date

2015-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1241-2015