Particulate reported by a customer has prompted Hospira Inc. to voluntarily recall ketorolac tromethamine injection USP in the United States and Singapore, FDA is reporting on its Web site. The recalled lots were distributed from February 2013 to December 2014 in the United States and from January 2014 to July 2014 in Singapore, the agency reports.
With “visible, floating particulate” reported in the glass flip-top vials, Hospira has begun to investigate in order to find the root cause and corrective and preventive actions. So far the company has not received reports of any adverse events associated with this issue for these lots to date.
Recalled products should be quarantined.
For more details on who to contact, please see FDA’s post.
Last year FDA reported that Hospira recalled one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL after a customer report of particulate in the primary container identified as a filamentous-like structure "indicative of mold." The product is packaged in 1000-mL flexible containers, one container per overwrap, and 12 overwrapped containers in each case, FDA explains on its Web site.