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GlaxoSmithKline is voluntarily recalling more than 590,000 albuterol inhalers (brand name Ventolin), citing a defect that may cause the inhalers to deliver fewer doses of the medicine than prescribed, the British drugmaker announced.
Patients complained about a bulging of the outside wrapper of Ventolin's packaging; a leak of the medicine's propellant is suspected to be to blame.
The recall involves three lots of the Ventolin HFA 200D inhalers:
- Lot # 6ZP0003
- Lot # 6ZP9944
- Lot # 6ZP9848.
The devices, manufactured at GSK's plant in Zebulon, North Carolina, have been recalled from hospitals, pharmacies, retailers and wholesalers in the U.S.
The defect does not pose any specific health risk, other than the risk of running out of albuterol prematurely. Patients are not advised to return inhalers from these lots. However, patients with inhalers in the affected lots can call 1-888-825-5249 to reach GSK's customer service center with questions.
"We currently don't anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue," GSK said in a statement.