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High RiskFDA
Med Tec Inc
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) dev...
Medical Devices·28 affected·Apr 15, 2019
High RiskFDA
Hitachi America, Ltd., Power Systems Division
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Medical Devices·3 affected·Apr 15, 2019
High RiskFDA
Schreiber Foods Inc
Shredded and blocks of Colby & Monterey Jack cheese - Labeled and Packaged: 1) Great Value, Finely Shredded, Colby & Monterey Jack Ch...
Dairy·64,549 affected·Apr 14, 2019
High RiskFDA
Mondelez Global Llc
Chewy Chips Ahoy Cookie (13 OZ)
Bakery & Grains·59,768 affected·Apr 13, 2019
High RiskFDA
Hilmar Cheese Company, Inc.
Colby Jack Cheese in 40 pound and 640 pound blocks
Dairy·203,928 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·60 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, C...
Drugs·1,357 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·5,678 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·6,746 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·475 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sod...
Injectable Drugs·110 affected·Apr 12, 2019
High RiskFDA
Teva Pharmaceuticals Usa
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79...
Oral Drugs·171,488 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, ...
Drugs·1,135 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bld...
Drugs·40 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·3,690 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·87 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·100 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,...
Drugs·215 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·196 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·737 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, N...
Drugs·532 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,233 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,...
Drugs·705 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·3,007 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·97 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·6,667 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Ch...
Drugs·1,310 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·15 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,783 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·2,567 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·715 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlott...
Drugs·40 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·2,162 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, N...
Drugs·118 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·532 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·390 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, C...
Drugs·150 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,475 affected·Apr 12, 2019
High RiskFDA
Omnilife Science Inc.
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument ...
Medical Implants·9 affected·Apr 12, 2019
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: ...
Medical Devices·244,268 affected·Apr 12, 2019
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Us...
Medical Devices·244,268 affected·Apr 12, 2019
High RiskFDA
Bard Peripheral Vascular Inc
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., ...
Surgical Devices·150 affected·Apr 12, 2019
High RiskFDA
Tecan Us, Inc.
Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liqui...
Medical Devices·40 affected·Apr 12, 2019
High RiskFDA
Patagonia Provisions Inc
Patagonia Provisions Classic Barbecue Savory Seeds; 1 oz. poly-film pouches. 12 units per case Vegan, Gluten Free Distributed by...
Food·27,588 affected·Apr 11, 2019
High RiskFDA
Patagonia Provisions Inc
Patagonia Provisions Savory Seeds Variety Pack; Classic Barbecue, Chipolte Lime, Mellow Curry 1 oz. poly-film pouches, 12 packages per ...
Snacks & Candy·21,576 affected·Apr 11, 2019
High RiskFDA
Patagonia Provisions Inc
Patagonia Provisions Mellow Curry Savory Seeds; 1 oz. poly-film pouches. 12 pouches per case Vegan, Gluten Free Distributed by Pat...
Food·20,460 affected·Apr 11, 2019
High RiskFDA
Patagonia Provisions Inc
Patagonia Provisions Chipotle Lime Savory Seeds; 1 oz. poly-film pouches. 12 pouches per case Vegan, Gluten Free Distributed by Pa...
Snacks & Candy·21,972 affected·Apr 11, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05),...
Oral Drugs·33,958 affected·Apr 11, 2019