ZEBULON, N.C. (CBS) – More than 593,000 asthma inhalers in the United States have been recalled because of a problem that could cause them to deliver less medication than intended.
An FDA document indicates the reason for the recall is a “defective delivery system” due to a leak in the Ventolin inhalers. Reuters reports drugmaker GSK is trying to figure out what caused the problem after an increasing number of complaints, and is pulling the inhalers from hospitals, pharmacies, retailers and wholesalers.
“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 said in a statement posted on the Asthma and Allergy Foundation of America website.
GSK says patients using the inhalers are not in danger, so they don’t need to return the product.
The recalled inhalers have a lot number of 6ZP9848, 6ZP0003 or 6ZP9944 and expire in March or April of 2018.