FDA-Drug2015-07-22Class 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; identified as calcium salt of Ketorolac

Sold states
Nationwide, Puerto Rico, Guam, Canada and Singapore
Affected count
12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Manufactured in
600 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-1241-2015

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