GlaxoSmithKline (GSK) has issued a voluntary Class II recall for three batches of its Ventolin HFA 200D inhalers, totaling over 593,000 units. The recall only affects hospitals, pharmacies, wholesalers and retailers and will not require patients to return their medication. Ventolin inhalers are used to treat a number of conditions, but are primarily prescribed as a treatment for asthma.
The decision to instigate a voluntary recall was taken by GSK following complaints about the packaging of some of the inhalers, a spokesman told the Asthma and Allergy Foundation of America (AAFA). In some cases, the pouches of affected lots inflated, causing leakage and risk inhalers would contain fewer doses than the number shown on the counter. The U.S. Food & Drug Administration (FDA) defines a Class II recall as one as in which use or exposure to a defective product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
In a statement released to the AAFA, GSK stated: "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."
The affected lot numbers are:
Pharmacy supplies should not be affected by the recall, but patients with any further questions should contact GSK's response center at 1-888-825-5249.
What are Ventolin Inhalers?
Ventolin HFA (albuterol) is a bronchodilator used to relaxed muscles in the airway and improve airflow to the lungs. It is often prescribed to patients with reversible obstructive airway disease, to prevent exercise-induced bronchospasm and treat asthma. Ventolin is a prescription inhaled beta-agonist appropriate for patients aged 4 and older. Common side effects that patients may experience are: sore throat, upper respiratory tract infection, cough, muscle pain and chest pain. Other medication used to treat patients with asthma include prednisone and other corticosteroids.