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 1,706 vials of L-Cysteine PF due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 135 bottles of Cyclo/PE/Trop PF eye drops nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 562 vials of Zinc Sulfate 1 mg/mL due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 14,325 syringes of Glycopyrrolate USP due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 589 vials of Brompheniramine Maleate due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 11 vials of Phenylephrine 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 1,386 vials of Testosterone EO-Pro-Cyp 220 due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling MIC Combo multi-dose vials because deficient practices may have impacted 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 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 5,919 vials of Morphine PF due to deficient practices that may impact 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 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide 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.
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 6,008 vials of Betamethasone SP PF due to deficient practices that may impact 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 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact 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 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide 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.