Hospira Issues Recall of Generic Painkiller

Hospira has issued a voluntary recall of ketorolac tromethamine injection, USP in the U.S. and Singapore due to potential particulate. The generic painkiller is widely used in hospitals and is now in short supply. The presence of particulate has been confirmed through a customer report of visible, floating particulate, identified as calcium-ketorolac crystals, in glass fliptop vials. More than 60 lots are impacted by this recall. 
 
If particulates are not observed prior to administration, intramuscular (IM) or intravenous (IV) administration theoretically could result in localized inflammation, allergic reaction, granuloma formation or microembolic effects (IV only).    
 
The lots were distributed from February 2013 to December 2014 in the U.S. and from January 2014 to July 2014 in Singapore. Hospira has not received reports of any adverse events associated with this issue for these lots to date, but has instructed customers to stop using any of the recalled vials.
 
The company, which started an investigation to determine the root cause and corrective and preventive actions, has had numerous manufacturing-quality compliance issues in recent years. Hospira recently agreed to be acquired by Pfizer for approximately $17 billion.