Mylan Voluntarily Recalls Devices of 13 Lots after Reports of Few of Them Not Working Emerged

Mylan investors had all reasons for concern when the company announced the recall of its EpiPens post market hours on Friday. The manufacturer of EpiPen Jr. Auto-Injector and EpiPens voluntarily recalled certain models after the reports came in that there was failure to activate the device properly and thus the medication was not deployed effectively. The company thus recalled certain models across seven countries other than the US, which includes Australia, Norway, and Japan.

In a statement, the company said, “The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.”

The recall was initiated after there were two complaints – both outside of the United States – about the device not getting activated probably due to a defect in a supplier component. It’s believed that this defect will make it difficult to operate the device in case of emergency situations and can be life-threatening for anaphylaxis patients.

Both the reported incidents pointed to the same batch of instruments that was recalled earlier too. Though the defect is extremely rare and the company did not find any defected unit during the testing and analysis of the potentially impacted lots, the recall is more of a precautionary measure.

The defective batch of EpiPen Jr 2-Pak and EpiPen 2-Pak were distributed during the period December 2015 – July 2016. The government agency FDA (Food and Drug Administration) clarified that not all pens are defective and it’s only a small number, hence not everyone needs to get worried. The agency said that it has the complete list of lot numbers and NDC numbers and the people can check if their EpiPens are recalled or not by tallying it with the  lot numbers on the side of their EpiPen packaging.

If you find your pen defective, you can report it at FDA’s Medwatch website. The company is providing the consumers with replacement pens, which they can collect from pharmacies nationwide, but the consumers’ first need to contact Mylan directly either by calling at their number 800-796-9526 or sending an email with details of their defective EpiPen at their email Id.

The company, however, insisted that until the customers get the replacement they should keep the defective pens with them as not all pens from the 13 lots in question are malfunctioning. Hence, it can come handy in case of an emergency.

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