FDA (Drugs) recall action 75695
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Fallon Wellness Pharmacy is recalling 5 vials of PAPA/PHEN/PROST injection due to environmental monitoring excursions that raise concerns about sterility assurance.
Fallon Wellness Pharmacy is recalling 10 vials of PAPA/PHEN/PROST injection due to environmental monitoring excursions that raise concerns about sterility assurance.