GlaxoSmithKline Plc, a British drugmaker, is recalling over 593,000 Ventolin asthma inhalers from pharmacies, hospitals, wholesalers, and retailers in the United States. The recall is voluntary and does not pose a direct threat to patients using the inhaler.
GSK initiated the recall due to packaging and leakage issues of the inhaler, which results in providing lesser doses than it is supposed to.
GSK's Ventolin Asthma Inhaler Recall: What Prompted The Move?
GSK revealed that it received several complaints regarding the inhaler's defective packaging and leakage, which prompted the drugmaker to take this decision. The outer wrapping of the inhaler was reported to be swelling up. This was suspected to be an indication of a leakage in the stimulator, which provides the medicine.
Three batches of the Ventolin HFA 200D inhalers, which were manufactured at GSK's factory based in North California's Zebulon, have been recalled.
The United States Food and Drug Administration accepted the recall proposal. The FDA labeled the recall process Level 2. Juan Carlos, the spokesman of GSK stated that the process will only be applicable for the products in the United States, as is the rule for Level 2 recalls.
According to the FDA, Level 2 recall indicates that using a product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
GSK affirmed that although it is working toward identifying the reason behind the defect, the company continues to manufacture the inhalers in its Zebulon plant.
"We currently don't anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue," stated GSK.
Previous Recalls By GSK
This is not the first recall by GSK with regard to its inhalers. Around 15 months ago, the drugmaker recalled almost 13,000 inhalers. At the time, the company was worried that some of the inhalers may not contain adequate propellant to provide the 200 doses of medicine, as promised by the inhaler's label.
GSK Increases Production Of Respiratory Products
GSK, in recent years, has been expanding the manufacturing of its respiratory line of products. In 2016, the company built a 48,437-square-feet factory in Ware, UK, worth $80.5 million. This was done to increase the production of Ellipta inhalers to almost 37 million every year.
In February this year, the drugmaker shared plans of opening a four-floor facility in Scotland. The $137 million factory will be utilized to produce the API in Ventolin i.e. Salbutamol.