After an elevated number of complaints, drugmaker GSK Plc announced on Tuesday that it is voluntarily recalling nearly 600,000 Ventolin asthma inhalers from hospitals, pharmacies, wholesalers and retailers in the United States.
According to Reuters, the affected products have a defect that causes them to deliver a smaller dose of medicine than indicated, which results from a leak in the propellant that delivers the medicine. The U.S. Food and Drug Administration has approved the “Level 2” recall, which means the product may cause temporary or medically reversible side effects.
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The affected inhalers come from three manufacturing lots at a plant in Zebulon, North Carolina. The lot numbers are 6ZP0003, 6ZP9944, and 6ZP9848. The plant is currently still making the inhalers, but GSK says it has plans to identify the issue and take corrective action.
GSK released a statement to the Asthma and Allergy Foundation of America saying: “Though the overall benefit-risk assessment for Ventolin® HFA 200D Inhaler when used at prescribed doses remains favorable, 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.”
If you have a question you can call the company’s response center at 1-888-825-5249.