FDA recall D-1124-2017

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.

Distribution

Distributed throughout the United States

Key facts

Status

Terminated

Initiation date

2017-08-15

Report date

2017-09-06

Termination date

2019-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rancho Cucamonga, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2017