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Nationwide Recall For Mylan's EpiPen Over Potential Defect

Nationwide Recall For Mylan's EpiPen Over Potential Defect”

So far, the USA recall covers 13 EpiPen lots distributed from December 17, 2015, to July 1, 2016.

EpiPen Jr (0.15 mg epinephrine) auto-injector lot 5GR765, expiry date March 2017.

Mylan NV said it was expanding a recall of its EpiPen allergy injection to the United States, 10 days after it issued a recall of more than 80,000 devices around the world.

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The defect makes it hard for the EpiPen to work during an emergency and could have significant health consequences for someone who is experiencing an allergic reaction. The defect occurs rarely and testing did not identify any product lots with a defect.

The recall notice stresses that both reports of the device failing to activate were related to the previously recalled lot and the incidences of the defects are extremely rare, however, the recall has been expanded out of an abundance of caution.

Pfizer said it's committed to replacing the recalled devices at no cost and has advised consumers who have them to contact its information line at 1-800-463-6001.

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Patients should keep their existing product until their replacement product can be secured. This company also makes a Generic EpiPen that is not included in the recall, according to ABC 15.

This voluntary recall is being conducted with the knowledge of FDA.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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