Pharmaceutical company GlaxoSmithKline has just voluntarily recalled nearly 600,000 asthma inhalers distributed within the US and Puerto Rico over safety concerns. At issue are three lots of Ventolin HFA 200D, which, according to the Asthma and Allergy Foundation of America, have triggered consumer complaints.
A company spokesperson told the AAFA that the complaints revolved around the “the overwrap, or pouches containing the inhalers, becoming inflated by leaking from the product.” As a result, the dosage counter on the products may be slightly off.
In the FDA’s report, the recalled inhalers are classified as a “Class II” concern, which means that the units “might cause a temporary health problem, or pose only a slight threat of a serious nature.”
The company’s official statement on the recall claims the “the overall benefit-risk assessment for Ventolin HFA 200D Inhaler when used at prescribed doses remains favorable,” but that “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.”
Consumers with concerns are advised to call GSK at 1-888-825-5249. In the meantime, you can check the lot numbers for the recalled products here.
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(Photo via AAFA)