Problems with leaking asthma inhalers has resulted in the recall of about 600,000 Ventolin HFA 200D inhalers, which may fail to deliver enough of a dose to alleviate asthma symptoms.
GlaxoSmithKline announced a Ventolin HFA 200D inhaler recall through the Asthma and Allergy Foundation (AAFA) of America on April 4, indicating that it would be a pharmacy-level recall and not one that would require consumers to turn in or exchange their inhalers. The recall came following complaints of the devices leaking.
According to the complaints, the leaks cause the overwrap pouches containing the inhalers to become inflated and bulge. The leaks mean that the devices may not deliver the number of doses indicated on the dose counter, which could lead to incomplete dosing.
Patients who do not experience a full dose may experience diminished bronchodilation during acute bronchospasm if they are relying on the rescue inhaler.
The inhaler is used among asthmatics and people with chronic obstructive pulmonary disease to deliver a metered-dose of albuterol to the airway and lungs during an asthma attack. The medication would open the airways in the lungs and allow the patient to breathe properly.
Health officials labeled the recall a level II recall because it does not pose an immediate threat or danger to the health of users. While patient’s may experience side effects, the side effects are temporary or reversible and are not considered life threatening. The likelihood of serious side effects is low.
Three lots of Ventolin HFA 200D asthma inhalers in the U.S. are affected by the recall. The lot numbers include 6ZP0003, 6ZP9944 and 6ZP9848. The inhalers are manufactured at a GSK plant in Zebulon, North Carolina.
GlaxoSmithKline is still attempting to identify the cause of the problem and plans to take corrective action. However, the company is still producing the Ventolin inhalers in North Carolina. GSK also indicated there will be no impact to the asthma inhaler supply as a result of the recall.
Patients can contact GlaxoSmithKline customer service at 888-825-5249 with any questions. If their asthma inhaler is failing to work and they are still experiencing symptoms they should seek medical treatment immediately.