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 11,363 vials of Methylprednisolone/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic drops nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling specific lots of Voriconazole eye drops because deficient practices may have compromised sterility assurance.
US Compounding Inc is recalling 439 vials of Medroxyprogesterone/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling Phenylephrine PF Sterile Solution (2.5%) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling Phenylephrine 10% PF Ophthalmic Solution because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 1,736 vials of MIC-Combo injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.