Hospira Inc. recalls KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fore…

Recall date

June 30, 2015

Source

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

Recall number

D-1242-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide, Puerto Rico, Guam, Canada and Singapore

Why it was recalled

Crystallization; identified as calcium salt of Ketorolac

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, 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