Dive Brief:
- British drugmaker GlaxoSmithKline is voluntarily recalling three lots of its 200-dose Ventolin (albuterol) inhalers from hospitals, pharmacies and wholesalers.
- Glaxo continues to investigate the issue to identify the root cause, a spokesperson for the company said in response to an emailed request for comment. The recall only affects the U.S. market and does not extend to patients.
- The recall appears to be a response to an increased number of complaints about damaged packaging that suggested a propellant leak, according to a report from Reuters.
Dive Insight:
This isn't the first time Glaxo has had to recall Ventolin inhalers. In December 2015, the company voluntarily recalled around 129,000 Ventolin HFA inhalers because of insufficient propellant to deliver the 200 doses.
This recall is broader, covering nearly 600,000 inhalers. Both recalls were of inhalers made at a Glaxo facility in Zebulon, North Carolina, according to Reuters.
Glaxo's Ventolin inhalers have been available since 1969, and are used by many of the 25 million asthmatics in the U.S. Behind the drugmaker's flagship Advair franchise, Ventolin is the second-highest earning product in Glaxo's respiratory portfolio. U.S. sales totaled £141 million ($176 million) in the fourth quarter 2016, despite the availability of generic versions of the albuterol inhaler.
The company is working to correct the manufacturing issue. Recalled products include Lot numbers 6ZP0003, 6ZP9944, 6ZP9848.