FDA (Drugs) recall action 69519
The FDA (Drugs) publishes a recall like this one as 56 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 56 pages.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..
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.
Oregon Compounding Centers is recalling Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Prednisolone Sodium Phosphate ophthalmic drops due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin injections due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Ganciclovir syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
Oregon Compounding Centers is recalling Sodium Chloride Inhalation 7% solution due to quality control issues affecting sterility assurance.