Ketorolac Tromethamine Injection (Hikma) - Particulate Matter (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
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 Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Brand
Hikma Pharmaceuticals USA Inc.
Lot Codes / Batch Numbers
Lot #: 038366, Exp. Date Mar 2020, 048365, 048367, Exp. Date Apr 2020, 078301, 078303, Exp. Date July 2020, 118358, Exp. Date Nov 2020, 029353, Exp. Date Feb 2021, 019413, Exp. Date Jan 2021
Products Sold
Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
Hikma Pharmaceuticals USA Inc. is recalling Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01 due to Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS). 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
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
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