Class II Ongoing

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

Company: Hospira Inc.
Recall Initiated: June 30, 2015
Posted: July 22, 2015
Recall Number: D-1242-2015
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
Firm Location: Lake Forest, IL, United States

Reason for Recall

Crystallization; identified as calcium salt of Ketorolac

Distribution

Nationwide, Puerto Rico, Guam, Canada and Singapore

Lot / Code Info

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

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