There were reliable reports of some glass particulate matter in a vial released to a hospital. So Merck decided to recall all 22,000 vials from that manuafcturing lot -- without FDA prompting. Makes sense (and yes, that's a throwback graphic, at right). And it won't matter to Merck's financial results.
The average selling price of Cubicin® has fallen considerably, since July 2020, when Sandoz began making a generic version available. So the financial impact of this recall is clearly immaterial. [Merck had acquired the drug, and its originating company, in January 2015, for about $8 billion; backgrounder there.] And the latest, from Yahoo! News:
. . .[Merck] is voluntarily recalling one lot of CUBICIN (daptomycin for injection) 500 mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. . . .
The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution. . . .
That's all I've got, from the old power alley this morning -- except to mention that the Gates Foundation will partner with Merck, and make up to $120 million available -- in nations with less disposable income -- treating molnupravir, the oral COVID-19 candidate now in priority clinical trials (for emergency approval), as an "essential medicine." Just as we said would transpire, the average prevailing price there. . . is already being moderated, pre-full FDA approval.
नमस्ते
on a brighter note: https://www.yahoo.com/gma/donald-trump-versus-electric-avenues-175632669.html
ReplyDeleteGrinning, indeed -- that is the same opinion and order we discussed here, in September:
ReplyDeletehttps://shearlingsplowed.blogspot.com/2021/09/tangerine-motion-to-dismiss-denied-eddy.html
Tangerine will indeed lose. It is all over, save for the shouting about how many millions of dollars he will owe.
Great find -- nice update!
Do speak freely, at 11:44 am -- I am here.
ReplyDelete