WASHINGTON — Nearly 600,000 asthma inhalers have been recalled because of a “defective delivery system,” according to the Food and Drug Administration.
The recall affects approximately 593,000 prescription-only inhalers produced by GlaxoSmithKline, the FDA’s website said. They were distributed nationwide.
GlaxoSmithKline initiated a voluntary recall of the product on April 4, according to Asthma and Allergy Foundation of America’s website.
Three lots of Ventolin HFA 200D Inhalers are impacted; they have lot numbers of 6ZP9848, 6ZP0003 and 6ZP9944.
Elaborating on the reason for the recall, the FDA cited an “elevated number of units with out of specification results for leak rate.”
In a statement released to AAFA, the company 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.”
Click here for more information about the recalled inhalers.