GlaxoSmithKline Recalls 600,000 Asthma Inhalers in US

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The recall was issued because of a defective delivery system; the units affected had possible package leakage.

GlaxoSmithKline (GSK) is recalling nearly 600,000 asthma inhalers in the United States because of a defective delivery system, according to an FDA Enforcement Report. The report stated that 593,088 Ventolin HFA 200D (albuterol) inhalers, produced at GSK’s Zebulon plant in North Carolina, had out-of-specification leak rates. The lots affected are 6ZP9848, 6ZP0003, and 6ZP9944.

In a statement released to the Asthma and Allergy foundation of America (AAFA), GSK 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 is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause.”


Source: FDA, AAFA