FDA (Drugs) recall action 80416
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 Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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.
La Vita Compounding Pharmacy is recalling Methyl Folate CA+ 1mg/ml Injection vials because production methods raised questions about the sterility of the drug product.
La Vita Compounding Pharmacy is recalling Methylcobalamin 1mg/mL Injection vials because production methods raised questions about the sterility of the drug product.
La Vita Compounding Pharmacy is recalling 191 vials of Glutathione 200mg/mL Injection because production methods raised questions about the sterility of the drug product.