The recall stemmed from a customer report of visible, floating particulates identified as “calcium-ketorolac crystals
Singapore: Just 5 days after Pfizer agreed to buy Hospira in a $16 bn deal, Hospira has recalled more than 60 lots of a generic painkiller vial due to contamination by crystal particles that could cause serious problems if injected into patients.
The US-based company said in its press release that it is voluntarily recalling vials of ketorolac tromethamine that were distributed in the US from February 2013 to December 2014, and in Singapore from January to July 2014.
The company further stated that the particles could cause localized inflammation and allergic reactions if injected intravenously and also added that it did not receive reports of any adverse reactions so far.
A Hospira spokeswoman said to a news agency that the company has begun an investigation to determine the root cause of the incident and to take proper corrective and preventive actions.
For long now, Hospira has been continuously facing quality issues with the FDA and has recalled many drugs. In late December, Hospira started a global recall of 10 lots of the cancer med mitoxantrone that was manufactured at Australian plant that the FDA spanked in a warning letter for not figuring out why tests showed its potency was too low and its impurities too high.
