Mylan Initiates Voluntary Recall of 13 EpiPen Lots Due to Potential Defects

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Pharmaceutical giant Mylan has announced a voluntary recall of specific lots of EpiPen and EpiPen Jr. devices across the United States due to concerns over possible defects. These devices are critical for individuals facing severe allergic reactions, prompting Mylan to take precautionary measures to prevent any compromised units from remaining in circulation.

In their recall notice, Mylan stated that while the likelihood of encountering a defect is low, they are taking this step “out of an abundance of caution.” The decision to recall was influenced by two previously reported incidents outside the U.S., where devices failed to activate because of a defect related to a supplier component. Both cases were linked to a single lot that has already undergone recall, leading to the expansion of this recall to include additional lots for safety.

The defect, if present, could result in an EpiPen that either requires excessive force to activate or fails to activate entirely, delaying crucial treatment for severe allergic reactions. The recall encompasses EpiPen and EpiPen Jr. lots distributed between December 17, 2015, and July 1, 2016. Consumers are encouraged to check the lots they possess and consult Mylan’s website for instructions on obtaining a replacement EpiPen. Mylan has advised users to retain their current pens until replacements are provided.

This is not the first instance in which Mylan has faced scrutiny regarding its EpiPen product. The company’s dramatic price increase for the device sparked significant public backlash last summer, prompting them to reduce the price from an exorbitant $600 to $300, despite the actual manufacturing cost being only $30. While the EpiPen remains costly, Mylan’s proactive stance on safety is commendable.

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In summary, Mylan’s recall of 13 lots of EpiPen and EpiPen Jr. devices is a precautionary measure taken in response to potential defects that could affect the activation of these life-saving devices. Users should verify their products against the recall list and follow Mylan’s guidance for replacements.