Published: Tue, April 04, 2017
Economy | By Melissa Porter

Mylan's EpiPen Recall Expanded to U.S.

Mylan's EpiPen Recall Expanded to U.S.

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.

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the United States of failure to activate the device due to a potential defect in a supplier component.

Mylan's EpiPen has been recalled across the U.S. It's believed that this defect will make it hard to operate the device in case of emergency situations and can be life-threatening for anaphylaxis patients. Both reports are related to the single lot that was previously recalled.

The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare". The lots affected in the United States are 5GM631, 5GM640, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, and 6GM087 (regular EpiPen, 0.3 mg), and 5GN767, 5GN773, and 6GN215 (EpiPen Jr., 0.15 mg).

People who have EpiPen or EpiPen Jr. devices can check the 2-pack cartons or the auto-injectors themselves for lot numbers and expiration dates. Apparently, patients were able to obtain the treatment only after receiving an alternate EpiPen, said Mylan.

Mylan on March 22 announced a recall of about 81,000 EpiPens distributed in Australia, New Zealand, Europe and Japan after two separate reports of the device failing to work properly during an emergency. Patients, customers and distributors are being notified and should refer to for updates on product return and replacement instructions. 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. Generic EpiPens are not included in this recent recall. "Recalls on epinephrine auto-injectors have occurred in the past", she says, "but overall, the reliability of these devices has been excellent". Hence, it can come handy in case of an emergency.

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