Posted by: nyguy
« on: September 29, 2017, 10:06:16 AM »Are there more serial / lot numbers recalled now? Wanting to be sure son has enuf supposedly ok Epipens for now.
No new recalls but my faith in Mylan at this point is gone.
Sanofi/Intelliject (Intelliject renamed them selves to Kaleo) had a little over a couple dozen reports of malfunctions (with no fatalities) and they hard stop did a full recall of Auvi-Q, with Sanofi reverting the rights to Kaleo, Kaleo doing a post-mortem and making sweeping manufacturing/testing changes, and bringing it back to market.
Meridian (making the drug) had hundreds of reports of issues including multiple deaths. In certain cases, they confirmed that deformed/malfunctioning specific components were at fault, and then did not look to see if other units in the same lot had the same defective component or issue a recall.
The fact that EpiPen has been around for decades is no comfort because it was redesigned in 2009 and the year of a redesign says nothing about the continuous quality of an autoinjector, failures and manufacturing defects can happen at any time. If they aren't adequately QCing them, randomly auditing lots, and then properly assessing product failures and erring on the side of caution for recalls then I don't have any confidence that newer lots are necessarily properly built.
Since I have commercial insurance and can get Auvi-Q for free, that's where my faith is. If not, I would look to get covered for the generic from Lineage.