According to the Food and Drug Administration, nearly 600,000 asthma inhalers have been recalled due to a “defective delivery system.”
Affecting asthma inhalers sold nationwide, the recall includes approximately 593,000 prescription-only inhalers produced by GlaxoSmithKline due to possible package leaks.
The pharmaceutical giant issued a voluntary recall of the product on April 4, stating three lots of Ventolin HFA 200D are affected. Their lot numbers 6ZP9848, 6ZP0003 and 6ZP9944.
Explaining the reason for the recall, the FDA cited an “elevated number of units with out of specification results for leak rate.”
The company said, “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 adds that they are committed to supplying high quality products and patient satisfaction, and hope to resolve this issue immediately.
If you have a question, call the company’s response line at 1-888-825-5249.