Reported Jul 22, 2015 · Ongoing
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 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, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
- Lot codes and dates
31077DK31078DK31338DK31339DK31340DKEXP 01JUL201532068DK32069DKEXP 01AUG291533270DKEXP 01SEP201534084DK34085DK34161DK34162DK34298DK34299DK34300DKEXP 01OCT201535011DK35081DK35082DK35116DKEXP 01NOV201538139DK38140DK36144DKEXP 01FEB201639256DK39257DKEXP 01MAR201642210DK42227DKEXP01JUN201643017DK43116DK43117DK43292DK43293DKEXP 01JUL201645034DK45035DK45118DK45120DKEXP 01SEP201646310DK46311DKEXP 01OCT2016 AND NOVAPLUS LOTS 32106DK32220DK32221DKEXP 01AUG201533235DK33236DKEXP 01SEP201534163DK34164DKEXP 01OCT201539263DK39264DKEXP 01MAR2016
- Amount recalled
- 12,460,975 vials(Hospira label); 3,016,500 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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