Inhalers can be tricky devices to manufacture and for the second time in two weeks a drugmaker is having to recall inhalers because the devices may not deliver any drugs. Following last week's recall by AstraZeneca ($AZN) of asthma inhalers in Denmark, Boehringer Ingelheim is recalling in the U.S. tens of thousands of inhalers used to treat chronic obstructive pulmonary disease.
According to the most recent FDA Enforcement Report, Boehringer Ingelheim is recalling one lot consisting of 358,647 Combivent Respimat inhalers because the delivery system is defective and may provide insufficient spray, or none at all. The propellant-free inhalers, which the company is voluntarily recalling, were manufactured in Germany.
Last week, AstraZeneca issued a recall in Denmark of a lot of its Bricanyl Turbuhalers after discovering they may contain no powder.
Boehringer Ingelheim several years ago made a big push in respiratory drugs and has twice expanded production at its inhaler plant in Dortmund, Germany. This year it was slated to begin production from its newest addition, an €85 million ($110 million) expansion that added 3,100 square meters and upped production capacity to 44 million inhalers.
Facing a tough time in its pharma business, however, Boehringer Ingelheim has more recently been shedding assets. Last year, it sold its Ben Venue Laboratories sterile injectables business and more recently its Roxane Labs generic drug business, both to Jordan-based Hikma. As part of its $2.65 billion in cash and stock for Roxane, Hikma gets a plant in Columbus, OH, that in addition to making solids, liquids, and nasal sprays, manufactures dry powder inhalers.
- here's the FDA recall notice