2015 Auvi-Q EpiPen Recall

In 2015, Sanofi recalled all Auvi-Q auto-injectors, which totaled around 490,000 packs, following 26 unconfirmed reports of incorrect dose delivery; however, no injuries or deaths were reported. The product relaunched in 2017 under Kaleo, offering improved manufacturing and a $0 out-of-pocket plan, but it failed to significantly dent EpiPen's 85-90% U.S. market share.

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