FDA-Drug2015-07-22Class II

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

Hospira Inc.
Hazard

Crystallization; identified as calcium salt of Ketorolac

Sold states
Nationwide, Puerto Rico, Guam, Canada and Singapore
Affected count
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1242-2015

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