Mylan Initiates Voluntary Recall of EpiPen and EpiPen Jr. Devices

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Pharmaceutical company Mylan has initiated a voluntary recall of 13 lots of EpiPen and EpiPen Jr. devices due to concerns about a potential defect that could affect their functionality. This proactive measure underscores the importance of these devices, which are critical for individuals facing severe allergic reactions.

Details of the Recall

Details from Mylan’s official recall notice indicate that while the likelihood of encountering a defect is low, the company is prioritizing safety by removing any potentially faulty units from circulation. This decision comes in light of two separate reports from outside the U.S. regarding devices that failed to activate, attributed to a defect in a component supplied by a third party. Notably, both reports were linked to a previously recalled lot, prompting Mylan to expand the recall to additional lots as a precaution. It was emphasized that “the incidence of the defect is extremely rare,” and thorough testing has not uncovered any defective units among the potentially affected lots.

Potential Risks

If the defect exists, it may hinder the EpiPen’s activation, either by requiring excessive force or resulting in total failure, which could delay emergency treatment during an allergic reaction. The current recall pertains to EpiPen and EpiPen Jr. devices distributed between December 17, 2015, and July 1, 2016. Users are advised to check their devices against the list of recalled lots and consult Mylan’s website for instructions on securing replacements. The company recommends holding onto the existing pens until a new one can be obtained.

Previous Controversies

This recall follows previous controversies surrounding Mylan, particularly regarding the significant price hikes for the EpiPen, which drew widespread backlash last summer. In response, the company reduced the price from $600 to $300, despite the manufacturing cost being only $30.

Commitment to Safety

In light of the importance of having reliable medical devices, it is reassuring to see Mylan taking these steps to ensure user safety. For those interested in family planning and pregnancy resources, you may find useful information at womenshealth.gov, and for tips on home insemination, check out Make a Mom. If you are exploring self insemination options, consider visiting Make a Mom for more insights.

Conclusion

In summary, Mylan’s voluntary recall of EpiPen lots highlights the company’s commitment to safety amidst concerns about device reliability. Users are encouraged to verify their devices and seek replacements if necessary.

Keyphrase: Mylan EpiPen recall

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