FDA Warns Maker of EpiPens of Unsafe Manufacturing Practices

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The Food and Drug Administration sent a warning letter this week to a facility owned by Pfizer which manufactures EpiPens for the drugmaker Mylan. In its letter, it cited that there were “significant violations of current good manufacturing practices.”

Apparently, the FDA has received hundreds of complaints between 2014 and 2017 about EpiPens failing to work properly. At least some of those individuals died from allergic reactions. The FDA claims that the company owned by Pfizer, Meridian Medical Technologies, failed to thoroughly investigate either the complaints or the deaths. The FDA also mentioned in its letter that Meridian continues to manufacture EpiPens that contain a defective component that could fail to properly operate during activation.

The company disagrees, stating publicly that it is confident in the safety of its EpiPens, although acknowledging that it is continuing to work with the FDA to resolve the points that were raised. The company also stated that it is not unusual to receive product complaints for products that were often administered by non-medical professionals.

If you currently have some EpiPens that you anticipate you may need to use in the future, you should check with the company to make sure that your EpiPens have not been recalled. If they have, you may want to buy some generic EpiPens. Also, you should make sure you always have at least two with you – one may fail, or you may need a second dose. EpiPens expire, so you should make sure to replace before the expiration date. Finally, you may forget how to use your EpiPen over time, or you may never have learned how to properly use it in the first place. You should get trained in how to properly use it if you aren’t completely comfortable. Ask your doctor or your pharmacist for more information.

If you believe that you were harmed by a defective EpiPen, call the Houston personal injury attorneys at Kennedy Hodges. They can help. Call today at 855-947-0707, or visit their YouTube channel to learn more.  

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