Reported Apr 15, 2015 · Terminated
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. · 275 N Field Dr · Lake Forest, IL · 60045-2579
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
7 of 7 products
Products covered by this recall # Product as published 1 NDC 0409-3796-01, Lot number: 26-098-DK, Exp. Date:1FEB2015 2 Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015 3 Lot number: 34-540-DK, Exp. Date:1OCT2015 4 Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016 5 Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016 6 Lot number: 44-076-DK, Exp. Date:1AUG2016 7 Lot number: 45-240-DK, Exp. Date:1SEP2016 and Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label NDC 0409-3796-49, Lot number: 26-097-DK, Exp. Date:1FEB2015. - Amount recalled
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
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
Why it was recalled
Crystallization
This product could cause temporary or reversible health problems — stop using it.
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