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FDAFDA · Food and drugs·Recall number D-1242-2015

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

Published July 22, 2015 · Recall initiated: June 30, 2015

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Crystallization; identified as calcium salt of Ketorolac

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
KETOROLAC TROMETHAMINE
Manufacturer
Hospira Inc.
Distributor
Nationwide, Puerto Rico, Guam, Canada and Singapore
Lot
31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
Risk classification
Class II
Area (FDA)
drug
Country
United States

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