As I predicted, Mylan has expanded the EpiPen recall to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA). The expanded voluntary recall is being initiated in the U.S. and will also extend to additional markets in Europe, Asia, North and South America. In contrast to the first recall announcement that related only to the 0.3 mg injector, this recall now impacts both the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector.
Mylan states in the press release that none of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. This seems extremely strange to me, unless the defect relates to the label, since the generic is exactly the same device, just without the label. I think Mylan is trying to boost sales of the generic before they get recalled too.
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To read the press release regarding the expanded recall included the affected lot numbers and expiry dates, click here.
To read my previous article about the recall, click here.