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High RiskFDA
American Pharmaceutical Ingredients Llc
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, pac...
Drugs·8,300 affected·Feb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25...
Drugs·1,050,000 affected·Feb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-...
Drugs·106,200 affected·Feb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-...
Drugs·200,000 affected·Feb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (ND...
Drugs·52,000 affected·Feb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, ...
Drugs·5,800 affected·Feb 9, 2018
High RiskFDA
Vitalab Co Inc
Product packaged in the following ways A) Sonne's, No. 17, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.) Contents - 1...
Supplements·1,703 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems...
Medical Devices·119 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Surgical Devices·876 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Surgical Devices·3,196 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Surgical Devices·383 affected·Feb 8, 2018
High RiskFDA
Tornier, Inc
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005...
Medical Devices·32,253 affected·Feb 8, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Medical Devices·595 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Surgical Devices·2,835 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Surgical Devices·359 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produc...
Medical Devices·281 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inten...
Medical Devices·2 affected·Feb 8, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Medical Devices·6,906 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom...
Medical Implants·10 affected·Feb 8, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Medical Devices·12 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inte...
Medical Devices·591 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Surgical Devices·2,395 affected·Feb 8, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Medical Devices·5,416 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Surgical Devices·181 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·151 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t...
Medical Devices·172 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produ...
Medical Devices·6 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Surgical Devices·1,411 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Surgical Devices·1,551 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to pr...
Medical Devices·47 affected·Feb 8, 2018
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate ...
Medical Devices·32,189 affected·Feb 7, 2018
High RiskFDA
Getinge Us Sales Llc
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ...
Surgical Devices·5,214 affected·Feb 7, 2018
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids fro...
Medical Devices·32,189 affected·Feb 7, 2018
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway...
Medical Devices·32,189 affected·Feb 7, 2018
High RiskFDA
Medela Inc
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. ...
Medical Devices·778 affected·Feb 7, 2018
High RiskFDA
La Salsa Foods Inc
Pepitas - International Food Court brand, Thai Sweet Chili Roasted Pumpkin Kernels, 4 oz. vacuum sealed plastic bag, UPC 0 83066 16018 5 ...
Food·209 affected·Feb 6, 2018
High RiskFDA
Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 2...
Medical Devices·0 affected·Feb 6, 2018
High RiskFDA
Baxter Healthcare Corporation
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Medical Devices·2,800 affected·Feb 6, 2018
High RiskFDA
Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08...
Medical Devices·0 affected·Feb 6, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Greek Yogurt 0% Blueberry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-men...
Dairy·10,080 affected·Feb 5, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Greek Yogurt 0% Black Cherry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-me...
Dairy·8,976 affected·Feb 5, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Greek Yogurt 0% Plain 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
Dairy·5,040 affected·Feb 5, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Greek Yogurt 0% Vanilla 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mention...
Dairy·6,720 affected·Feb 5, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Greek Yogurt 0% Strawberry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-ment...
Dairy·9,804 affected·Feb 5, 2018
High RiskFDA
Meijer Distribution, Inc
Meijer Yogurt Blended Low-fat Blueberry 6 oz.The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
Dairy·15,084 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Drugs·21 affected·Feb 5, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Is...
Oral Drugs·1,157,095 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Injectable Drugs·500 affected·Feb 5, 2018