FDA (Drugs) recall action 75212
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
The agency’s own wording, quoted from the enforcement report.
The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection in Oklahoma because the medication was sterilized with a recalled filter.
The Apothecary Shoppe LLC is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL vials because they were sterilized with a recalled filter, raising concerns about sterility assurance.
The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.