Ketorolac Tromethamine Injection (Hospira) – Crystallization Risk (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Hospira Inc.
Lot Codes / Batch Numbers
NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015, Lot number 26-151-DK, Exp. Date:1FEB2015, Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015, Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015, Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015, Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015, Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016, Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016, Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016, Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016, Lot number: 41-078-DK, Exp. Date:1MAY2016, Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016, Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016, 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, Lot number: 35-229-DK, Exp. Date:1NOV2015, Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and Lot number: 40-534-DK, Exp. Date:1APR2016
Products Sold
NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015; Lot number 26-151-DK, Exp. Date:1FEB2015; Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015; Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015; Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015; Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015; Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016; Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016; Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016; Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016; Lot number: 41-078-DK, Exp. Date:1MAY2016; Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016; Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016; 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; Lot number: 35-229-DK, Exp. Date:1NOV2015; Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and Lot number: 40-534-DK, Exp. Date:1APR2016
Hospira Inc. is recalling KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hosp due to Crystallization. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Crystallization
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026