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
Reason for recall: Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Recall initiated: 20170815
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated