The Recall Desk

Archive

June 2013 recalls

533 recalls were announced in June 2013.

What the numbers show

Critical
24
Severe
199
High
169
Moderate
108
Low
33

Of the 533 recalls this month scored against our rubric, 5% are Critical, 37% are Severe.

101–200 of 533

  • SevereFDA (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
  • SevereFDA (Food)·F-1532-2013·2013-06-19

    Hazelnut Growers of Oregon Recalls In-Shell Hazelnuts for Salmonella Risk

    Hazelnut Growers of Oregon is recalling bulk in-shell hazelnuts due to potential Salmonella contamination. The product was distributed in Canada.

    Product
    Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in parts: "***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO.…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (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…
    Category
    Food
    Distribution
    7 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
  • 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
  • SevereNHTSA·13E034000·2013-06-19

    Ohlins Steering Dampers Recalled for Cracking Bracket Risk

    Ohlins is recalling steering dampers for BMW motorcycles because an incorrectly machined bracket may crack, potentially causing steering to lock and leading to injury or a crash.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    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…
    Category
    Food
    Distribution
    20 states
  • 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.…
    Category
    Medical Device
    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.…
    Category
    Medical Device
    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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    20 states
  • 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-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…
    Category
    Medical Device
    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…
    Category
    Food
    Distribution
    20 states
  • 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…
    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…
    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…
    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…
    Category
    Food
    Distribution
    20 states
  • 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-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…
    Category
    Food
    Distribution
    20 states
  • 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…
    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…
    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
  • 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…
    Category
    Medical Device
    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
  • 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…
    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 (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…
    Category
    Food
    Distribution
    20 states
  • 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 (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.…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    20 states
  • 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
  • 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
  • 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…
    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-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…
    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…
    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…
    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-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…
    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·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·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·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·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
  • 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
  • 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·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
  • 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 (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
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-515-2013·2013-06-12

    TG United Recalls ED A-Hist Tablets Due to Underdosing

    TG United, Inc. is recalling ED A-Hist Tablets because they are underdosed or have an incorrect dosage regime.

    Product
    ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1454-2013·2013-06-12

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

    Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.

    Product
    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-585-2013·2013-06-12

    Pentec Health Recalls Intradialytic Parenteral Nutrition Bags Due to Sterility Concerns

    Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.

    Product
    IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-540-2013·2013-06-12

    TG United Recalls Tri-Dex PE Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling 12,198 bottles of Tri-Dex PE because the product is underdosed or has an incorrect dosage regime.

    Product
    Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
    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-555-2013·2013-06-12

    Dexamethasone Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-504-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Syrup Bottles

    TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.

    Product
    AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
    Category
    Drug
    Distribution
    5 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-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 (Drugs)·D-557-2013·2013-06-12

    Sodium EDTA Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling 43 vials of Sodium EDTA Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-561-2013·2013-06-12

    Methylcobalamin Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Methylcobalamin 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-550-2013·2013-06-12

    Baclofen Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Baclofen 500 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Baclofen 500 mcg/mL Injectable, 22 mL vial, 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-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 (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-537-2013·2013-06-12

    TG United Recalls TL-DEX DM Cough Suppressant Due to Dosage Errors

    TG United, Inc. is recalling 2,532 bottles of TL-DEX DM cough suppressant because the product is underdosed or has an incorrect dosage regime.

    Product
    TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2013·2013-06-12

    Symbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.

    Product
    Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-510-2013·2013-06-12

    TG United Recalls AMBI Cough Syrup Due to Underdosing

    TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.

    Product
    AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-531-2013·2013-06-12

    TG United Recalls Poly-Vent Tablets Due to Incorrect Dosage

    TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.

    Product
    Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-563-2013·2013-06-12

    Compounded Ascorbic Acid Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-517-2013·2013-06-12

    TG United Recalls Dallergy Tablets Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling Dallergy tablets because they are underdosed or have an incorrect dosage regime. The recall affects specific lots distributed in five states.

    Product
    Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-569-2013·2013-06-12

    Carnosine 5% Eye Drops Recalled for Sterility Concerns

    The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1469-2013·2013-06-12

    Recall of Versaport Bladeless Optical Trocar Due to Seal Disengagement

    FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF 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 entry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-565-2013·2013-06-12

    Phosphatidyl Choline Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Phosphatidyl Choline 10% Injectable due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-562-2013·2013-06-12

    FDA Recalls Procaine Injectable Due to Sterility Concerns

    The FDA is recalling Procaine 1% Injectable vials due to quality control concerns regarding sterility assurance. The affected products were distributed in four states.

    Product
    Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-556-2013·2013-06-12

    FDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns

    The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1475-2013·2013-06-12

    LL Bakery Recalls Bread and Danish for Undeclared Milk Allergen

    LL Bakery is recalling specific bread and Danish products because the labels fail to declare milk as an allergen in the whey powder.

    Product
    Butter Farm Enriched White Bread 16 oz (454g), 9pc/box. UPC 0 10314 10004 4. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-571-2013·2013-06-12

    Compounded MIC Injectable Recalled Due to Sterility Concerns

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

    Product
    MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states

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