FDA (Drugs) recall action 72179
The FDA (Drugs) publishes a recall like this one as 59 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 59 pages.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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.
US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,421 vials of Lincomycin/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.