Reported Jul 22, 2015 · Ongoing

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

Hospira Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hospira Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • 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
Lot codes and dates
    • 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
Amount recalled
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Crystallization; identified as calcium salt of Ketorolac

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.