British pharmaceutical giant GlaxoSmithKline (GSK) is recalling nearly 600,000 asthma inhalers in the US due to a defect in the delivery system.
The recall was classified as a Class II recall, which means "the products might cause a temporary health problem, or pose only a slight threat of a serious nature," according to the US Food and Drug Administration (FDA).
The recalled product is Ventolin HFA (albuterol sulfate) Inhalation Aerosol, which were made at its plant in Zebulon, North Carolina.
The Ventolin inhalers impacted have three lots numbers of 6ZP9848, 6ZP0003 and 6ZP9944.
The defect does not pose a danger to patients, so the FDA has not asked consumers to return inhalers they have already purchased.
GSK said it was trying to identify the root cause of the problem and would take corrective action.
In a statement released to the Asthma and Allergy Foundation of America, GSK said, ''Though the overall benefit-risk assessment for Ventolin HFA 200D Inhaler when used at prescribed doses remains favourable, in this situation, there is possible risk to patients of experiencing diminished bronchodilation in the setting of acute bronchospasm if reliant on a rescue inhaler that could potentially not deliver the stated number of actuations.''
''GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause,'' the statement added.
This latest recall comes 15 months after GSK recalled nearly 130,000 inhalers over concerns that some inhalers did not contain sufficient propellant to deliver the 200 doses its label said it can provide through the end of its shelf life.