Reported Apr 15, 2015 · Terminated
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. · 275 N Field Dr · Lake Forest, IL · 60045-2579
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
16 of 16 products
Products covered by this recall # Product as published 1 NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015 2 Lot number 26-151-DK, Exp. Date:1FEB2015 3 Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015 4 Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015 5 Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015 6 Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015 7 Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016 8 Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016 9 Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016 10 Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016 11 Lot number: 41-078-DK, Exp. Date:1MAY2016 12 Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016 13 Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016 14 Lot number: 46-043-DK, 46-044-DK, 46-047-DK, Exp. Date:1OCT2016 AND NOVAPLUS LABEL NDC 0409-3795-49, Lot number: 27-101-DK, Exp. Date:1MAR2015 15 Lot number: 35-229-DK, Exp. Date:1NOV2015 16 Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and Lot number: 40-534-DK, Exp. Date:1APR2016 - Amount recalled
- HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 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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