The Recall Desk

Archive

June 2013 recalls

533 recalls were announced in June 2013.

What the numbers show

Critical
24
Severe
176
High
192
Moderate
108
Low
33

Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.

101–200 of 533

  • SevereCPSC·13221·2013-06-19

    Kolcraft Recalls Jeep Liberty Strollers Due to Wheel Projectile Hazard

    Kolcraft is recalling Jeep Liberty strollers because tire inner tubes can rupture, causing wheel rims to fly off as projectiles. The defect has resulted in 18 reported injuries.

    Product
    Jeep Liberty Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1505-2013·2013-06-19

    Pure Herbs Protein Extract Recalled for Undeclared Milk and Soy Allergens

    Pure Herbs, Ltd. is recalling Natural Herbal Extracts Protein Dietary Supplement bottles because they contain undeclared milk and soy allergens, posing a risk of serious allergic reactions.

    Product
    Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1520-2013·2013-06-19

    Trophy Nut Pistachios Recalled Due to Salmonella Contamination Risk

    Trophy Nut Co Inc is recalling 6 oz. natural pistachios because they were made with pistachios that may be contaminated with Salmonella.

    Product
    Trophy Nut Brand 6 oz. natural pistachios
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2013·2013-06-19

    Edwards Recalls QuickDraw Venous Cannula Due to Separation Complaints

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.

    Product
    QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one ship
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2013·2013-06-19

    DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement

    DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.

    Product
    DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2013·2013-06-19

    Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 815 UltraClip breast tissue markers because they were distributed without completing the sterilization process.

    Product
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2013·2013-06-19

    Bard UltraClip breast tissue marker recall due to separation risk

    Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.

    Product
    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2013·2013-06-19

    Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.

    Product
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2013·2013-06-19

    Endologix AFX Introducer System Recalled for Dilator Breakage

    Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.

    Product
    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1523-2013·2013-06-19

    XYMOGEN Artriphen Recalled for Undeclared Soy and Milk Allergens

    XYMOGEN Artriphen joint supplement is being recalled because the label fails to declare soy and milk, posing a risk to allergic consumers.

    Product
    XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles
    Category
    Food
    Distribution
    42 states
  • HighFDA (Food)·F-1510-2013·2013-06-19

    Purely American Recalls Garlic Pasta Stir Fry Mix for Missing Wheat Label

    Purely American, Inc. is recalling 73 bags of Gilroy Garlic Pasta Stir Fry Mix because the labels are missing the required wheat allergen declaration.

    Product
    GILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, black pepper, garlic powder, salt.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelya
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1521-2013·2013-06-19

    Applied Medical Recalls Epix and Direct Drive Laparoscopic Graspers

    Applied Medical is recalling specific lots of Epix and Direct Drive Laparoscopic Graspers because the trigger may fracture, potentially leaving the jaws closed.

    Product
    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13740·2013-06-19

    Polaris Recalls 2011 Ranger RZR XP 900 Vehicles Due to Burn Hazard

    Polaris is recalling about 4,500 2011 Ranger RZR XP 900 off-highway vehicles because the firewall can overheat and melt, posing a burn risk.

    Product
    2011 Polaris Ranger RZR XP 900 recreational off-highway vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1506-2013·2013-06-19

    Purely American Chicken Noodle Soup Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling Chicken Noodle Soup Mix because some labels are missing the required wheat allergen declaration.

    Product
    Chicken Noodle Soup Mix, "9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1529-2013·2013-06-19

    Market Pantry Sweet & Salty Mix Recalled for Undeclared Milk Allergen

    American Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts with undeclared milk.

    Product
    Market Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY, May contain tree nuts, milk, wheat and eggs. Distributed by Target Corporatio
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1540-2013·2013-06-19

    Abbott STAR S4 Excimer Laser System Recalled for Potential Inadvertent Firing

    Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1531-2013·2013-06-19

    Whole Foods Recalls Natures Path Granola for Undeclared Almonds

    Whole Foods Market is recalling Natures Path Hemp Plus Granola sold in bulk bins because it may contain undeclared almond slices.

    Product
    Natures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2013·2013-06-19

    Abbott STAR S4 IR Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13220·2013-06-19

    Easton Recalls Axis Arrows Due to Breakage and Injury Hazard

    Easton is recalling specific batches of Axis archery arrows because they can break when fired, posing a risk of injury to users and bystanders.

    Product
    Easton Axis arrows
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1514-2013·2013-06-19

    Purely American Orange Drop Cookie Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling Indian River Orange Drop Cookies Mix because the labels are missing the required wheat allergen declaration.

    Product
    INDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange peel, baking powder, and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 001
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1528-2013·2013-06-19

    Bard MicroSheath and Usher Catheters Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 17 MicroSheath and Usher support catheters because they were distributed without completing the sterilization process.

    Product
    MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2013·2013-06-19

    Abbott STAR S3 Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2013·2013-06-19

    Purely American Pasta Salad Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling specific 10 oz bags of Pasta Salad Mix because the labels are missing the required wheat allergen declaration.

    Product
    Pasta Salad Mix, "10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, parsley, celery seed, garlic, paprika, and spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1530-2013·2013-06-19

    Ethicon Recalls Echelon 60mm Endoscopic Linear Cutter Reloads

    Ethicon Endo-Surgery is voluntarily recalling Echelon 60mm endoscopic linear cutter reloads worldwide due to potential reload damage that could cause incomplete staple line formation.

    Product
    ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2013·2013-06-19

    Purely American Santa Fe Cornbread Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling Santa Fe Cornbread Mix because the labels are missing the required wheat allergen declaration.

    Product
    SANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell peppers, celery & parsley flakes, non-aluminum baking powder, baking soda, salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (80
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1529-2013·2013-06-19

    Bard Usher Support Catheters Recalled for Incomplete Sterilization

    Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.

    Product
    USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single lu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1527-2013·2013-06-19

    Southwest Ice Cream Specialties Recalls Ice Cream for Undeclared Allergens

    Southwest Ice Cream Specialties is recalling 1,524 cartons of ice cream because the product may contain undeclared pecan, soy, and/or wheat allergens.

    Product
    "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)" is displayed on the carton's label in error. The lid bears the label "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1534-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1509-2013·2013-06-19

    Pasta Toss Mix Recalled for Missing Wheat Allergen Labeling

    Purely American, Inc. is recalling Adirondack Getaway Pasta Toss Mix because some labels are missing the required wheat allergen declaration.

    Product
    ADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes, and garlic.***PURELY AMERICAN 5991 Industrial Park Road, Athens,
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1525-2013·2013-06-19

    Uncle Eddies Vegan Oatmeal Chocolate Cookies Recalled for Undeclared Walnuts

    International Desserts is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies because they may contain undeclared walnuts.

    Product
    Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:"uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1515-2013·2013-06-19

    Purely American Apple and Spice Cake Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling Shenandoah Valley Apple and Spice Cake Mix because some labels are missing the required wheat allergen declaration.

    Product
    SHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 001
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1512-2013·2013-06-19

    Purely American Recalls Minestrone Soup Mix for Missing Wheat Allergen Label

    Purely American, Inc. is recalling 413 bags of Mama Marino's Minestrone Soup Mix because the labels are missing the required wheat allergen declaration.

    Product
    MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN 599
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1526-2013·2013-06-19

    Dairy Fresh Recalls IGA Ice Cream for Undeclared Allergens

    Dairy Fresh LLC is recalling IGA Brand Vanilla & Chocolate Ice Cream because it contains undeclared almonds, coconut, and soy lecithin.

    Product
    IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1511-2013·2013-06-19

    Purely American Seafood Chowder Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling 15 oz bags of Long Island Baymen Seafood Chowder Mix because the labels are missing the required wheat allergen declaration.

    Product
    LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road, Athens,
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1508-2013·2013-06-19

    Purely American Pasta Salad Mix Recalled for Missing Wheat Allergen Labeling

    Purely American, Inc. is recalling specific varieties of Pasta Salad Mix because the labels are missing the required wheat allergen declaration.

    Product
    Pasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes and garlic***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purely
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1525-2013·2013-06-19

    Siemens MicroScan Dried Negative Breakpoint Combo 47 Panels Recalled

    Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.

    Product
    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1543-2013·2013-06-19

    Utah Medical Products Recalls Deltran Disposable Pressure Transducer Kits

    Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.

    Product
    Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2013·2013-06-19

    International Biomedical Recalls VIA Medical Collection Bags Due to Connector Issues

    International Biomedical is recalling VIA Medical Collection Bags because the connector can become occluded if the luer lock is over-tightened.

    Product
    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2013·2013-06-19

    Embla Embletta Gold Recalled for Calibration Error Affecting Sleep Therapy

    Embla System LLC is recalling 519 Embletta Gold polysomnography recorders due to a calibration error that may lead to over-titration of sleep therapy.

    Product
    embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (exclud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2013·2013-06-19

    Bard Vaccess PTA Balloon Catheters Recalled for Incorrect Diameter Labeling

    Bard Peripheral Vascular is recalling Vaccess PTA Balloon Dilatation Catheters because the inflation hub may display an incorrect balloon diameter.

    Product
    BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of ob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1516-2013·2013-06-19

    Purely American Carrot Cake Mix Recalled for Missing Wheat Allergen Labeling

    Purely American, Inc. is recalling Marin County Carrot Cake Mix because the labels are missing the required wheat allergen declaration.

    Product
    MARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 001
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1518-2013·2013-06-19

    American Optisurgical Recalls TX1 Tissue Removal System Handpieces

    American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.

    Product
    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2013·2013-06-19

    StarDental Classique Diamond Dental Bur Recall for Coating Adhesion Issues

    Dental EZ Stardental Division is recalling 3,560 StarDental Classique Diamond Dental Burs because a manufacturing issue prevented the diamond coating from adhering properly to the shank.

    Product
    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1523-2013·2013-06-19

    Fenwal Recalls AMICUS Exchange Kits Due to Labeling Error

    Fenwal is voluntarily recalling 114 AMICUS Exchange Kits because the product was cleared for European use only but distributed in the US.

    Product
    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-599-2013·2013-06-19

    Actavis Recalls Fentanyl Transdermal Systems Due to Impurity Specifications

    Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, because they failed impurities and degradation specifications.

    Product
    Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1530-2013·2013-06-19

    Berkshire Cheese LLC Recalls Blue Cheese Due to Non-Pathogenic E. Coli Contamination

    Berkshire Cheese LLC is recalling Berkshire Blue Cheese due to non-pathogenic E. Coli contamination. The product was distributed in Massachusetts.

    Product
    Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·13V251000·2013-06-18

    Forest River Recalls 2014 Motorhomes Due to Battery Short Circuit Risk

    Forest River is recalling 289 model year 2014 Sunseeker, Forester, Lexington, and Solera motorhomes because a battery isolation manager short circuit could cause smoke or fire.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, SOLERA, LEXINGTON, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13217·2013-06-18

    BeBeLove Recalls Baby Bath Seats Due to Drowning Hazard

    BeBeLove is recalling about 5,600 E-Zee Bath Seats because they can tip over, posing a drowning risk to babies. No injuries have been reported.

    Product
    Baby Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13219·2013-06-18

    Idea Baby Bath Seats Recalled for Drowning Risk

    Chelsea & Scott is recalling Idea Baby Bath Seats because they can tip over, posing a drowning hazard to infants.

    Product
    Idea Baby Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13737·2013-06-17

    Sam's Club Recalls Outdoor Seating Groups Due to Fall Hazard

    Sam's Club is recalling Metro and Montero outdoor seating groups because swivel bases can break, posing a fall hazard. No injuries have been reported.

    Product
    Metro 6-piece Outdoor Seating Group and Montero 4-piece Outdoor Seating Group
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V246000·2013-06-13

    Honda Recalls 2006-2007 S2000 and 2006 Acura RSX for Brake Booster Defect

    Honda is recalling specific 2006-2007 S2000 and 2006 Acura RSX vehicles because the brake booster may lose vacuum, reducing braking assistance and increasing crash risk.

    Product
    HONDA — HONDA, ACURA S2000, RSX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V247000·2013-06-13

    NABI Transit Buses Recalled for Loose Air Brake Pedal Mounting

    North American Bus Industries is recalling 2003-2013 45CLFW and 2013 40CLFW transit buses because the air brake pedal mounting may become loose, increasing crash risk.

    Product
    NABI — NABI 45CLFW, 40CLFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13214·2013-06-13

    Texsport Recalls Cedar Lake Propane Heater/Cookers Due to Fire Hazard

    Texsport is recalling about 325 Cedar Lake Propane Heater/Cookers because a malfunctioning regulator can cause propane to flare, posing a fire hazard.

    Product
    Cedar Lake Propane Heater/Cooker
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V248000·2013-06-13

    GM Recalls 2005-2007 SUVs for Door Module Fire Risk

    General Motors is recalling approximately 193,652 vehicles from 2005-2007 due to a driver's door module defect that could cause a fire.

    Product
    GMC — GMC, ISUZU, SAAB ENVOY, ASCENDER, 9-7X, TRAILBLAZER EXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13215·2013-06-13

    Stride Rite Recalls Girls' Sandals Due to Choking Hazard

    Stride Rite is recalling about 7,500 'Joanna' girl's sandals because the metal flower on top can detach, posing a choking hazard to children.

    Product
    Joanna Girl's Sandal
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1462-2013·2013-06-12

    Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.

    Product
    Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self conta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1456-2013·2013-06-12

    Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues

    Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.

    Product
    Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1469-2013·2013-06-12

    Whole Foods Salad Chicken Curry Recalled for Undeclared Egg Allergen

    Whole Foods Market Group Inc. is recalling 493 lbs of Salad Chicken Curry due to an undeclared egg allergen. The product was sold in six northeastern states.

    Product
    Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk)
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-532-2013·2013-06-12

    TG United Recalls Underdosed OTC Tablets Due to Manufacturing Deviations

    TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.

    Product
    TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-583-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-594-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1452-2013·2013-06-12

    Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates

    Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.

    Product
    Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 51004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-566-2013·2013-06-12

    Compounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns

    The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-534-2013·2013-06-12

    TG United Recalls CPM PSE DM Drops Due to Underdosing

    TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-525-2013·2013-06-12

    TG United Recalls BroveX PSE DM Due to CGMP Deviations

    TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.

    Product
    BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-587-2013·2013-06-12

    Pentec Health Recalls Proplete 52 Intradialytic Nutrition Due to Sterility Concerns

    Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-586-2013·2013-06-12

    Pentec Health Recalls Proplete 40 Intradialytic Parenteral Nutrition Bags

    Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-514-2013·2013-06-12

    Ryddex G Tablets Recalled for Underdosing and Incorrect Dosage Regime

    TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.

    Product
    Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-522-2013·2013-06-12

    TG United Recalls Maxifed DM Due to Underdosing and Incorrect Dosage Regime

    TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.

    Product
    Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-541-2013·2013-06-12

    TG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-511-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cold and Flu Syrup

    TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-560-2013·2013-06-12

    Mitomycin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-595-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-519-2013·2013-06-12

    TG United Recalls Brompheniramine/Pseudoephedrine DM Liquid Due to Underdosing

    TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.

    Product
    BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-521-2013·2013-06-12

    TG United Recalls Cardec DM Drops Due to Underdosing

    TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-512-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant Bottles

    TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.

    Product
    AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-593-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-558-2013·2013-06-12

    FDA Recalls Glutathione Injectable Due to Sterility Concerns

    The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-546-2013·2013-06-12

    TG United Recalls ZoDen PD Nasal Spray Due to Dosage Errors

    TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.

    Product
    ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1480-2013·2013-06-12

    Kreg Medical Recalls E-Z Wider Bariatric Chair Beds Due to Collapse

    Kreg Medical Inc. is recalling 59 E-Z Wider Bariatric Chair Beds because the bed frame collapsed during patient use, leaving the patient in a forward tilt position.

    Product
    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-544-2013·2013-06-12

    TG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage

    TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.

    Product
    Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1468-2013·2013-06-12

    FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

    The FDA is recalling 23,050 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-530-2013·2013-06-12

    TG United Recalls Poly-Vent DM Tablets Due to Dosage Deviations

    TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.

    Product
    Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-590-2013·2013-06-12

    Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.

    Product
    Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1470-2013·2013-06-12

    FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

    The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-509-2013·2013-06-12

    TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup

    TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-542-2013·2013-06-12

    TG United Recalls Trigofen DM Drops Due to Underdosing

    TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-559-2013·2013-06-12

    Lipoic Acid Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-567-2013·2013-06-12

    Testosterone Cypionate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1442-2013·2013-06-12

    Intuitive Surgical Recalls Monopolar Curved Scissors Due to Thermal Injury Risk

    Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.

    Product
    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-582-2013·2013-06-12

    Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.

    Product
    Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-523-2013·2013-06-12

    TG United Recalls Maxifed-G Due to Underdosing and Incorrect Dosage

    TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.

    Product
    Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
    Category
    Drug
    Distribution
    5 states

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