- FiercePharma Manufacturing reports that Hospira's ketorolac tromethamine recall is fast approaching the 40 million vial threshold. Ketorolac is a painkiller used during surgery and is now on the FDA shortage list.
- Last fall, Hospira recalled roughly 18 million vials of ketorolac, and now it has issued another recall for 20.7 million more vials.
- Ketorolac, which is an NSAID, has been on the shortage list since at least January of this year. It is generally available from Hospira and Fresenius Kabi.
The reason for the recall is due to crystallization of calcium salt in the ketorolac formulation. Hospira has been aggressive about policing the situation and trying to get ahead of it. In a statement emailed to FiercePharma Manufacturing, a Hospira spokesperson said: "In the last few years, Hospira has invested more than $1 billion across the company to help ensure high-quality products are available to patients in sustainable supply. We are proud of our progress, but our work is not done. We remain dedicated and focused across our global network to ensure that we are meeting all the requirements of global regulatory bodies, and executing on the commitments that we have made to ensure sustainable compliance across our entire manufacturing footprint."
For its part, Pfizer, which is in the process of acquiring Hospira for $15 billion, is well aware of the long list of quality-control problems that Hospira has faced and continues to face, not only in the U.S. and India, but also in Australia and Italy.
In fact, Hospira has had more class 1 recalls than any other biopharma company in the last several years. Nonetheless, Pfizer is sticking with its plans to follow through with the acqusition.