FDA-Drug2017-09-06Class II
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
Amphastar Pharmaceuticals, Inc.
Hazard
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Sold states
Distributed throughout the United States
Affected count
637,810 vials
Manufactured in
11570 6th St, N/A, Rancho Cucamonga, CA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2017Don't want to check this manually?
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