Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ketorolac Tromethamine Injection Recalled by Amphastar Pharmaceuticals, Inc. Due to Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amphastar Pharmaceuticals, Inc. directly.
Affected Products
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
Quantity: 637,810 vials
Why Was This Recalled?
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Where Was This Sold?
Distributed throughout the United States
About Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report