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

Recall Number: D-1124-2017

Firm: Amphastar Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170906

Initiation Date: 20170815

Termination Date: 20190114

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

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