FDA-Drug2015-04-15Class II

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

Hospira Inc.
Hazard

Crystallization

Sold states
U.S. Nationwide and International: Guam and Singapore.
Affected count
HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0482-2015

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