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The US Food and Drug Administration approved the recall of over 500,000 inhalers by leading pharmaceutical company GlaxoSmithKline because of a product defect.

The company announced the recall of over 500,000 inhalers after receiving a number of complaints about bulging of the wrapper outside of the product. The propellant of the medicine was said to be leaking out from the body of the inhaler. The products were manufactured in Zebulon, North Carolina, Reuters reported.

This recall of over 500,000 inhalers included three lots of the Ventolin HFA 200D inhalers. The leak of the propellant may cause inadequate doses of Ventolin to be delivered, the Atlanta Journal Constitution reported. The propellant is the gas that the drug is mixed with in order to be released in metered doses and acts similarly to pressurized gas in aerosols.

The FDA classifies this voluntary recall as a Class II recall which means that if a consumer is using a product, the probability of serious untoward effects on health is remote or can cause temporary or medically reversible aftereffects.

GlaxoSmithKline has already begun an investigation in their US manufacturing plant to identify the cause of the defect so they could correct it. Since the product defect is not dangerous, they are not asking the consumers to return the purchased product.

The company also maintains that this is not a consumer-level recall and is only limited to the retailers and wholesale buyers of the product. The recall is limited to products released in the United States.

The plant in North Carolina is still manufacturing the same product while the inside investigation still ongoing. Despite the recall, the pharmaceutical company still maintains that there will be no shortage or a supply impact of the product.

This comes on the heels of another product recall by GlaxoSmithKline 15 months ago where they pulled out around 130,000 canisters of the product that did not contain enough propellant that reduced the number of doses that was supposed to deliver.