Ketorolac Tromethamine 60mg (Hospira) – Crystallization (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, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
Brand
Hospira Inc.
Lot Codes / Batch Numbers
Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016, Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016, Lots 44-357-DK, 44-358-DK Exp. Date 1AUG2016
Products Sold
Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016; Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016; Lots 44-357-DK, 44-358-DK Exp. Date 1AUG2016; Lot 46-308-DK Exp. Date 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 38-137-DK Exp. Date 1FEB2016 - Note: The lot number may be followed by additional numbers from 01 to 99
Hospira Inc. is recalling Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc 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