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Recall Observatory FDA recall evidence

Drug product

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

D-1242-2015

June 30, 2015

Class II

Product summary

Firm
Hospira Inc.
Event
Event 71681
Status
Ongoing
Classification
Class II
Quantity
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
Official record key
drug-enforcement:D-1242-2015

Official wording

Reason: Crystallization; identified as calcium salt of Ketorolac

Code information: 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

Distribution pattern: Nationwide, Puerto Rico, Guam, Canada and Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization; identified as calcium salt of Ketorolac