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 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic 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 Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide 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 265 vials of Methylcobalamin injection 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 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact sterility assurance.
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 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 82 vials of Alprostadil (PGE-1) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 711 fentanyl syringes nationwide 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 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised 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 11,363 vials of Methylprednisolone/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 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 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide 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 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.