Ketorolac (Toradol) Recall by Hospira Creates Shortage in Hospitals

By Greg Webb, March 4, 2015

Hospira is voluntarily recalling 60 lots of vials of the generic drug, ketorolac tromethamine (also known as Toradol), due to contamination by crystal particles that could cause problems if injected into patients. To date there have been no reports of adverse events but the particulates could cause “localized inflammation, allergic reactions and other problems if they are injected or infused intravenously”, according to the company.

Hospira has experienced a number of manufacturing and quality problems over the last several years, which have resulted in recalls and product shortages.  The recall of Ketorolac, “ an injected nonsteroidal anti-inflammatory drug, or NSAID, which is given to patients during and after certain surgical procedures” means that hospitals will have to substitute other drugs. (Wall St. J., 2/12/15)  Ketorolac lessens the needs for patients to receive opioids, which have several unpleasant side effects.

Hospira manufactures 95% of the Ketorolac on the market, so this recall presents a challenge for those hospitals that routinely depend on the drug. Fresenius Kabi AG produces the remaining 5% and is stepping up its production to meet demand. Drug shortages and recalls are not uncommon but in a case like this it points out the challenges when problems occur in a commonly used drug.

Hospira settled a lawsuit in January related to its failure to deal with known manufacturing problems. Part of the lawsuits dealt with securities fraud, misleading investors and failing to handle fiduciary responsibilities. The company, recently purchased by Pfizer for $17 billion, must pay $2.6 million in attorneys’ fees and litigation expenses. In a different group of lawsuits the company was ordered to pay $60 million to some shareholders.