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High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·108 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·36 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·323 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·268 affected·Sep 14, 2015
High RiskFDA
Smiths Medical Asd, Inc.
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are...
Medical Implants·130 affected·Sep 14, 2015
High RiskFDA
Medtronic Navigation, Inc.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734...
Medical Devices·2,346 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·67 affected·Sep 14, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Medical Devices·109 affected·Sep 14, 2015
High RiskFDA
Encore Medical, Lp
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to...
Medical Implants·277 affected·Sep 14, 2015
High RiskFDA
Us Compounding Inc
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arka...
Injectable Drugs·7,852 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkan...
Injectable Drugs·5,919 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conw...
Topical Drugs·1,833 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conwa...
Injectable Drugs·542 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection,...
Injectable Drugs·854 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, ...
Drugs·82 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmac...
Injectable Drugs·13,843 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, A...
Topical Drugs·135 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy,...
Injectable Drugs·980 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway...
Injectable Drugs·14,325 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conw...
Injectable Drugs·100 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Co...
Topical Drugs·2 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compoundi...
Topical Drugs·1,198 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy...
Injectable Drugs·439 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72...
Injectable Drugs·14,580 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Co...
Injectable Drugs·1,421 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arka...
Injectable Drugs·1,706 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding ...
Topical Drugs·494 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharma...
Injectable Drugs·1,244 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansa...
Drugs·96 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, ...
Injectable Drugs·19,494 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile I...
Injectable Drugs·797 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compo...
Topical Drugs·3,860 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 6...
Drugs·589 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Dee...
Injectable Drugs·1,939 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, A...
Injectable Drugs·12,191 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway...
Injectable Drugs·3,629 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chr...
Injectable Drugs·1,093 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conwa...
Injectable Drugs·15,640 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Ophthalmic Drugs·2 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy...
Topical Drugs·1 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arka...
Topical Drugs·2,984 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding ...
Injectable Drugs·105 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conwa...
Injectable Drugs·33,778 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, A...
Topical Drugs·3 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Comp...
Injectable Drugs·103 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy,...
Injectable Drugs·1,590 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding P...
Injectable Drugs·5,118 affected·Sep 12, 2015
High RiskFDA
Us Compounding Inc
Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas...
Injectable Drugs·1,096 affected·Sep 12, 2015