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03 April 2017, 02:37 | Ignacio Smith
Matthew Orr STAT
The original memo was due to two reports of the company's allergy treatment failing to work in emergencies. The EpiPen's being recalled were distributed between December 2015 and July 2016 and includes the EpiPen Jr.in the United States. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty, according to the FDA's press release dated March 31, 2017. (0.15 mg) 2-Pak Auto-Injectors that carry expiration dates between April and October. The Mylan adult version are sold with a yellow label while the EpiPen Jr.is sold with a green label.
The FDA said the number of reported failures is small, but the lots are being recalled because failure to activate and treat a severe allergic reaction is a life-threatening risk.
The EpiPen intervention product administers doses of epinephrine to patients suffering from anaphylaxis resulting from extreme allergic reactions. The recall does not include Mylan's cheaper generic version that the company released late previous year. Furthermore, all patients should take comfort in knowing that the whole of this recall is being conducted with full and open supervision of the United States Food and Drug Administration.
"The expanded voluntary recall is being initiated in the US and also will extend to additional markets in Europe, Asia, North and South America", Mylan said.
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Mylan is already suffering from bad PR after the company introduced a 600 percent price hike for the life saving device past year, an increase the CEO argued was "fair".
The recalled items will be replaced at no cost.
The company said do not get rid of your current EpiPen until you have a replacement.
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