Ketorolac Tromethamine Injection (Amphastar) – crystallization risk (2017)
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 Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Brand
Amphastar Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot # XI002A6, XI003A6, Exp 12/17, XI004G6, XI005G6, Exp 6/18, XI007H6, Exp 7/18, XI00816, XI00916, XI01016, XI01116, Exp 8/18, XI012J6, XI013J6, Exp 9/18, XI015K6, Exp 10/18, XI016L6, Exp 11/18, XL018A7, XI019A7, Exp 12/18, XI020B7, XI021B7, Exp 1/19, XI022C7, XI023C7, Exp 2/19, XI025D7, Exp 3/19.
Products Sold
Lot # XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.
Amphastar Pharmaceuticals, Inc. is recalling Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphast due to Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.. 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: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
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