Amphastar Pharmaceuticals, Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals,
Recalled September 6, 2017 · FDA recall D-1124-2017 · Amphastar Pharmaceuticals
Hazard
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. · FDA Class II
Units
637,810 vials
Sold at
Distributed throughout the United States
Description
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
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
Manufacturer(s)
Amphastar Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →