GlaxoSmithKline LLC is recalling approximately 67,508 Anoro Ellipta (umeclidinium and vilanterol) inhalers because they failed release testing. The medication was found to have umeclidinium coarse particle mass that was outside of required specifications. No injuries or incidents have been reported in connection with this recall. These prescription inhalers were distributed nationwide to pharmacies in the United States and Puerto Rico.
Medication that falls outside of particle size specifications may not be delivered correctly to the lungs, which could potentially reduce the effectiveness of the treatment. No adverse health consequences have been reported to date.
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Rx Only. Quantity: 67,508 inhalers.
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Sources: FDA iRES · Raw API Response
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