Hospira Inc. recalls KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake For…

Recall date

January 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0482-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

U.S. Nationwide and International: Guam and Singapore.

Why it was recalled

Crystallization

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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