Recalls from injectable drug specialist Hospira ($HSP) are a regular occurrence, but the one announced by the FDA today comes at a particularly inopportune time. The FDA posted the recall in its weekly Enforcement Report on the same day that Pfizer ($PFE) announced it was buying Hospira in a $17 billion deal.
The Lake Forest, IL, company is recalling 126,075 vials of propofol after it received a complaint of particulate embedded in the neck of one vial that was identified as being primarily iron. This lot is one more in an ongoing recall that began last April when the company began retrieving 7 lots of the drug for the same problem. It said at the time that it had identified the issue and had taken steps to fix it.
The recall was posted on an FDA site today, even as Pfizer announced it intended to buy Hospira for its strong injectable drug business and its position in biosimilars, two areas that can build up Pfizer's established products business. Pfizer said it expects to be able to wring about $800 million in costs out of their combined operations.
Pfizer is taking on a company that has had perpetual issues with manufacturing quality cited by the FDA. It spent about $375 million to upgrade plants in the U.S. that were cited by the FDA in warning letters. It recently announced it intends to shut down one of those facilities; a plant in Clayton, NC, will close in June and 250 jobs will be lost. But the drugmaker has also had manufacturing issues at plants in India and in Australia, which have also been issued warning letters.
- here's the recall notice
- here's the Pfizer release