The Recall Desk

Archive

December 2013 recalls

1,402 recalls were announced in December 2013.

What the numbers show

Critical
351
Severe
605
High
191
Moderate
225
Low
30

Of the 1,402 recalls this month scored against our rubric, 25% are Critical, 43% are Severe.

301–400 of 1402

  • SevereFDA (Food)·F-0864-2014·2013-12-25

    Garden-Fresh Foods Recalls Various Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Grandpa's, Baked Beans, 2/5 lb., 0 11596 55180 7, 11/26/2013 - 12/9/2013
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0782-2014·2013-12-25

    National Enzyme Recalls Digestive Bul Powder for Chloramphenicol Contamination

    National Enzyme Co is recalling Bulk A957 Nutra Med Digestive Bul powder because it may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318);
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1053-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Finest Traditions, Southwest Taco Pasta, 1/8 lb., 10 733147 10287 6, 11/20/2013 - 12/9/2013
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0951-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables and ready-to-eat salads manufactured before November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Our Own, Garden Pasta Salad, 1/5 lb., 0 11596 52153 4, 11/22/2013 - 12/6/2013;
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0924-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Grandpa's, Cucumber Dill Dip, 1/5 lb.,0 11596 55900 1, 12/23/2013- 12/28/2013
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1130-2014·2013-12-25

    Senor Murphy Candymaker Recalls Multiple Candies Due to Undeclared Allergens

    Senor Murphy Candymaker is recalling eight types of candy products because they contain undeclared allergens.

    Product
    Senor Murphy Santa Fe Candymaker Chili Peanut Brittle , 4 oz and 1 lb. Handmade with sugar, corn syrup, peanuts, butter, soda, chile, and salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2014·2013-12-25

    Baxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk

    Baxter is voluntarily correcting ABACUS TPN software versions 2.0-3.0 because data corruption could cause patients to receive another patient's TPN order.

    Product
    ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2014·2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2014·2013-12-25

    GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems

    GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.

    Product
    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0947-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, and dips manufactured before November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Finest Traditions, Fresh Salsa Mild, 6/11 oz., 10 733147 109943, 12/9/2013;
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0384-2014·2013-12-25

    Taylor Farms Broccoli Crunch Kits Recalled for Listeria Risk

    Taylor Farms is recalling Broccoli Crunch Kits because the included salad dressing was recalled for possible Listeria monocytogenes contamination.

    Product
    Broccoli Crunch Kit 2 cnt w/ red Onion 10030223091285, 592500, TAYLOR FARMS TN, SMYRNA, TN 37167
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1102-2014·2013-12-25

    Turkey Hill Moose Tracks Frozen Dessert Recalled for Metal Debris

    Turkey Hill is voluntarily recalling Moose Tracks frozen dairy dessert due to potential metal debris contamination.

    Product
    Turkey Hill Stuff'd Moose Tracks Frozen Dairy Dessert Size: 1 Pint (473 ml), packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0520-2014·2013-12-25

    Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment

    Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.

    Product
    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1105-2014·2013-12-25

    Global Health Laboratories Recalls UT-Fem Urinary Tract Supplement

    Global Health Laboratories is recalling UT-Fem FOR WOMEN dietary supplements contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb.

    Product
    UT-Fem¿ FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1103-2014·2013-12-25

    Turkey Hill Pumpkin Pie Ice Cream Recalled for Metal Debris

    Turkey Hill Dairy is voluntarily recalling 756 tubs of Pumpkin Pie Premium Ice Cream due to potential metal debris contamination.

    Product
    Turkey Hill Pumpkin Pie Premium Ice Cream 48 oz. packaged in a paper tub and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1126-2014·2013-12-25

    Senor Murphy Candymaker Recalls Chocolate Pretzels for Undeclared Allergens

    Senor Murphy Candymaker is recalling Chocolate Pretzels and other confections due to undeclared allergens. Consumers should stop using the products.

    Product
    Senor Murphy Santa Fe Candymaker Chocolate Pretzels 3 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0919-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Garden-Fresh, Creamy Cole Slaw Dressing, 4/2 lb., 0 11596 43200 7, 12/17/2013 - 12/27/2013
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0545-2014·2013-12-25

    ASI Medical Recalls SEAC Advanced Dental Systems Due to Air Tank Rupture Risk

    ASI Medical is recalling 337 SEAC Advanced Dental Systems because the miniature plastic air tank can potentially rupture.

    Product
    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1034-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Roundy's, Salsa, 12/15 oz., 0 11596 06117 7, 0 11596 06117 7, 12/1/2013 - 12/9/2013;
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0944-2014·2013-12-25

    Garden-Fresh Foods Recalls Fresh Salsa Due to Listeria Risk

    Garden-Fresh Foods is recalling specific lots of Grandpa's and Our Own fresh salsa because they may be contaminated with Listeria monocytogenes.

    Product
    Grandpa's, Fresh Salsa, 1/5 lb., 0 11596 55912 4, 12/1/2013 - 12/12/2013; Grandpa's, Fresh Salsa, 4/5 lb., 0 11596 55913 1, 12/1/2013 - 12/12/2013; Our Own, Fresh Salsa , 1/5 lb., 0 11596 59021 9 , 11/22/213 - 12/9/2013 ;
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0386-2014·2013-12-25

    Taylor Farms Broccoli Slaw Kits Recalled for Listeria Risk

    Taylor Farms is recalling Broccoli Slaw Kits because they contained salad dressing from Reser's that was recalled for possible Listeria monocytogenes contamination.

    Product
    Broccoli Slaw Kit, 1/6.5#, 85004, TAYLOR FARMS TN, SMYRNA, TN 37167
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0536-2014·2013-12-25

    Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch

    Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.

    Product
    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1124-2014·2013-12-25

    Senor Murphy Candymaker Recalls Multiple Candies for Undeclared Allergens

    Senor Murphy Candymaker is recalling eight candy products due to undeclared allergens. Consumers should stop eating these items and check the recall list.

    Product
    Senor Murphy Santa Fe Candymaker Cashew Crunch , 4oz and 1 lb. Handmade with cashews, sugar, corn syrup, butter, soda, and salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0387-2014·2013-12-25

    Taylor Farms Recalls Giardiniera Salad Kits Due to Listeria Risk

    Taylor Farms Tennessee is recalling six Giardiniera Vegetable Salad Kits because the included dressing may be contaminated with Listeria monocytogenes.

    Product
    Giardiniera Vegetable Salad Kit 1cnt, 1/13#, 59431, TAYLOR FARMS TN, SMYRNA, TN 37167
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0522-2014·2013-12-25

    Mobility Unlimited Recalls KayserBetten IDA Beds Due to Door Joint Failure

    Mobility Unlimited Inc. is recalling 33 KayserBetten model IDA beds because door joints may loosen or separate, causing doors to drop outward and potentially injure users.

    Product
    KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2014·2013-12-25

    Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues

    Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.

    Product
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1128-2014·2013-12-25

    Senor Murphy Candymaker Recalls Multiple Confections for Undeclared Allergens

    Senor Murphy Candymaker is recalling eight confection products due to undeclared allergens. Consumers should stop eating these items and return them to the point of purchase.

    Product
    Senor Murphy Santa Fe Candymaker Pinon Brittle , 4 oz and 1 lb. Handmade with pinones (pine nuts), sugar, corn syrup, butter, soda, and salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2014·2013-12-25

    Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk

    Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.

    Product
    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2014·2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1127-2014·2013-12-25

    Senor Murphy Candymaker Recalls Multiple Products for Undeclared Allergens

    Senor Murphy Candymaker is recalling eight candy products due to undeclared allergens. The recall covers nationwide distribution.

    Product
    Senor Murphy Santa Fe Candymaker Chile Peanuts, 4 and 9 oz. Handmade with peanuts, sugar, corn syrup, brown sugar, butter, baking soda, Shimayo red chile, and salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1123-2014·2013-12-25

    Senor Murphy Candymaker Recalls Pecan Bueno for Undeclared Allergens

    Senor Murphy Candymaker is recalling Pecan Bueno and other products due to undeclared allergens. Consumers should stop eating these items.

    Product
    Senor Murphy Santa Fe Candymaker Pecan Bueno, 4oz and 1 lb. Handmade with pecans, sugar, corn syrup, butter, soda, and salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0946-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Farmer's Market, Fresh Salsa Jalapeno Mild, 6/15 oz., 0 11596 06142 9, 0 00 11596 06142 9, 12/14/2013 - 12/15/2013 ;
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0385-2014·2013-12-25

    Taylor Farms Recalls Broccoli Crunch Kits Due to Listeria Risk

    Taylor Farms is recalling Broccoli Crunch Kits because the included salad dressing was contaminated with Listeria monocytogenes.

    Product
    Broccoli Crunch Kit PP 92051229, SAFEWAY ITEM#, 1/7#, 59001, DISTRIBUTED BY LUCERNE FOODS, INC, PO BOX 99, PLEASANTON, CA 94566-0009, 1-877-232-4271
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1101-2014·2013-12-25

    Turkey Hill Chocolate Peanut Butter Cup Ice Cream Recalled for Metal Debris

    Turkey Hill Dairy is voluntarily recalling specific pints of Premium Chocolate Peanut Butter Cup Ice Cream due to potential contamination with metal debris.

    Product
    Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Size 1 Pint (473 ml) packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0518-2014·2013-12-25

    Kimberly-Clark Epidural Pain Management Trays Recalled for Syringe Defect

    Kimberly-Clark is recalling Single Shot Epidural Pain Management Trays because the included BD LOR Syringes may stall or stick.

    Product
    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1110-2014·2013-12-25

    Flora Double Ginger Herbal Tea Blend Recalled for Salmonella Contamination

    Flora Inc. is recalling Double Ginger Herbal Tea Blend due to Salmonella contamination. Consumers in 14 states should stop using the product.

    Product
    Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package. UPC 0 61998 63757 9 The product is labeled in parts: "***DOUBLE GINGER HERBAL TEA BLEND***FLORA***CERTIFIED ORGANIC***FRESH-SEALED TEA BAGS***16***NET WT 1.24 oz***(35.2 g)***INGREDIENTS: GINGER…
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-0525-2014·2013-12-25

    Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient results.

    Product
    VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1091-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Martin's, White French Dressing, 4/2 lb., 0 11596 55350 4, 11/16/2013 - 11/30/2013;
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0533-2014·2013-12-25

    Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect

    Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.

    Product
    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0949-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread, and dip products manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Finest Traditions, Fresh Salsa Spicy, 6/11 oz., 10 733147 10996 7, 12/9/2013
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0943-2014·2013-12-25

    Garden-Fresh Foods Recalls Cut Vegetables and Salads for Listeria Risk

    Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, and dips manufactured prior to November 6, 2013, due to potential Listeria monocytogenes contamination.

    Product
    Grandpa's, Fresh Mango Salsa, 1/5 lb., 0 11596 55916 2, 12/9/2013 - 12/12/2013
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0541-2014·2013-12-25

    Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.

    Product
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1125-2014·2013-12-25

    Senor Murphy Candymaker Recalls Chocolate Products Due to Undeclared Allergens

    Senor Murphy Candymaker is recalling multiple chocolate and nut products because they contain undeclared allergens.

    Product
    Senor Murphy Santa Fe Candymaker Chile Pistachio Bark , 2.5 oz and 1 lb. Handmade with dark chocolate (sugar, chocolate liquor processed with alkali, cocoa butter, milk fat, soy lecithin - an emulsifier, natural flavors), pistachios, chile, salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1100-2014·2013-12-25

    Source Naturals Essential Enzyme Ultra Recalled for Chloramphenicol Contamination

    Source Naturals Essential Enzyme Ultra is being recalled because it was made with bulk products containing chloramphenicol.

    Product
    Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120 count bottles. Vegetarian capsules Manufactured for: Source Naturals, Inc. Santa Cruz, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0383-2014·2013-12-25

    Taylor Farms Broccoli Crunch Kit Recalled for Listeria Risk

    Taylor Farms is recalling Broccoli Crunch Kits because the included salad dressing was contaminated with Listeria monocytogenes.

    Product
    Broccoli Crunch Kit 1 cnt, 432714, 59520, TAYLOR FARMS TN, SMYRNA, TN 37167
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0388-2014·2013-12-25

    Taylor Farms Spinach Antipasti Salad Kits Recalled for Listeria Risk

    Taylor Farms is recalling Spinach Antipasti Salad Kits because the included dressing was recalled for possible Listeria monocytogenes contamination.

    Product
    Spinach Antipasti Salad Kit 1cnt, 438405, 1/8#, 59433, TAYLOR FARMS TN, SMYRNA, TN 37167
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0768-2014·2013-12-25

    National Enzyme Recalls Carbgestkosh Capsules Due to Chloramphenicol Contamination

    National Enzyme Co is recalling bulk Carbgestkosh capsules because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2014·2013-12-25

    Arrow International Recalls Nerve Block Catheter Kits Due to Labeling Error

    Arrow International is recalling 121 Continuous Peripheral Nerve Block Catheter Kits because the packaging incorrectly describes the stimulator cable connector.

    Product
    Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1108-2014·2013-12-25

    Lsg Food World Recalls Noodles House Home Style Noodles for Unapproved Additives

    Lsg Food World Inc. is recalling Noodles House Home Style Noodles due to the use of an unapproved color and an undeclared food additive.

    Product
    NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801748; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0785-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0746-2014·2013-12-25

    National Enzyme Co Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028); (3) NWC Naturals Ultra Enzyme…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1107-2014·2013-12-25

    LSG Food World Recalls Noodles House Noodles for Unapproved Additives

    LSG Food World Inc. is recalling Noodles House Home Style Noodles due to the use of an unapproved color and an undeclared food additive.

    Product
    NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801724; *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0744-2014·2013-12-25

    National Enzyme Recalls Blue-Green Algae Supplements Due to Chloramphenicol

    National Enzyme Co is recalling Applied Health blue-green algae supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0810-2014·2013-12-25

    National Enzyme Recalls PerformanceZyme Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling PerformanceZyme dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label;
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0834-2014·2013-12-25

    Nature's Way Multivitamin Recalled for Potential Chloramphenicol Contamination

    Schwabe North America is voluntarily recalling Nature's Way Alive Whole Food Energizer Multivitamin because raw material enzymes may contain the antibiotic chloramphenicol.

    Product
    Nature's Way,UPC 33674150924, Alive Whole Food Energizer MultiVitamin ( No Iron Added), 90 Vcaps, 20009818
    Category
    Food
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0505-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0771-2014·2013-12-25

    National Enzyme Recalls Bulk Dige Capsules Due to Chloramphenicol

    National Enzyme Co is recalling bulk Dige capsules because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0752-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements Due to Potential Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling certain microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1106-2014·2013-12-25

    LSG Food World Recalls Noodles House Noodles for Unapproved Additives

    LSG Food World Inc. is recalling Noodles House Home Style Noodles due to the use of an unapproved color and an undeclared food additive.

    Product
    NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801731. *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0758-2014·2013-12-25

    National Enzyme Recalls Bulk Digestive Multi Supplements Due to Chloramphenicol

    National Enzyme Co is recalling bulk digestive supplements that may contain chloramphenicol above 0.3 ppb. The product was distributed domestically and internationally.

    Product
    Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0494-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling Excelsior microcatheters because they were shipped with use-by dates exceeding available shelf-life data.

    Product
    Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0745-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements for Potential Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0530-2014·2013-12-25

    Remel RapID Yeast Plus System Recalled for Mislabeled Reagents

    Remel Inc is recalling 150 kits of the RapID Yeast Plus System because the labels for Reagent A and Reagent B were reversed.

    Product
    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0510-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates that exceed available shelf-life data.

    Product
    Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-364-2014·2013-12-25

    Tween Brands Recalls Anti-Bac Hand Sanitizer Due to Labeling Error

    Tween Brands Inc is recalling 12,326 bottles of Yum Yum Bubble Gum Justice Anti-Bac hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0795-2014·2013-12-25

    National Enzyme Recalls Tribulus Supreme 2.0 Supplements Due to Chloramphenicol

    National Enzyme Co is recalling IMTWellnes Tribulus Supreme 2.0 dietary supplements because they may contain chloramphenicol above 0.3 ppb.

    Product
    IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0790-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements Due to Potential Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0502-2014·2013-12-25

    Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates that exceed available shelf-life data.

    Product
    Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0787-2014·2013-12-25

    National Enzyme Co Recalls Dietary Supplements Due to Chloramphenicol Contamination

    National Enzyme Co is recalling specific dietary supplements because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2)…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0503-2014·2013-12-25

    Stryker Neurovascular Medical Devices Recalled for Shelf-Life Labeling Errors

    Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates exceeding available shelf-life data.

    Product
    Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1113-2014·2013-12-25

    DRUK Orange Squash Recalled for Undeclared Sunset Yellow FCF

    Balajee Trade Link LLC is recalling DRUK Orange Squash because FDA analysis found it contains undeclared sunset yellow FCF.

    Product
    DRUK Orange Squash Contains 25% Orange Juice Net Wt. 24 fl oz. Imported by: Balajee Trade Link, LLC Scranton, PA USA Product of Bhutan
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0736-2014·2013-12-25

    National Enzyme Co Recalls Fiber Digestion Enzyme Supplement Due to Chloramphenicol

    National Enzyme Co is recalling ProSol Professional Solutions Fiber Digestion Enzyme Supplement because it may contain chloramphenicol above the permitted limit.

    Product
    ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0835-2014·2013-12-25

    Nature's Way Men's Energizer Tablets Recalled for Potential Antibiotic Contamination

    Schwabe North America is voluntarily recalling Nature's Way Alive Whole Food Energizer Men's tablets because raw material enzymes may contain the antibiotic chloramphenicol.

    Product
    Nature's Way,UPC 33674155424, Alive Whole Food Energizer Men's, 90 Tabs, 20010871
    Category
    Food
    Distribution
    47 states
  • ModerateFDA (Food)·F-0774-2014·2013-12-25

    National Enzyme Recalls Bulk Digestive Enzyme Powder for Chloramphenicol

    National Enzyme Co is recalling bulk digestive enzyme powder that may contain chloramphenicol above 0.3 ppb.

    Product
    Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0807-2014·2013-12-25

    National Enzyme Recalls Bulk C665 Powder Due to Chloramphenicol

    National Enzyme Co is recalling Bulk C665 powder because it may contain chloramphenicol levels exceeding 0.3 ppb. The product was distributed domestically and internationally.

    Product
    Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0804-2014·2013-12-25

    National Enzyme Recalls Cellulase Enzymes Due to Chloramphenicol Contamination

    National Enzyme Co is recalling Cellulase Cellulolytic Enzymes because the raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN;
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0772-2014·2013-12-25

    National Enzyme Co Recalls Bulk Dietary Supplement Capsules Due to Chloramphenicol

    National Enzyme Co is recalling bulk dietary supplement capsules because a raw material may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0800-2014·2013-12-25

    National Enzyme Co Recalls Bulk Enzyme Powder Due to Chloramphenicol

    National Enzyme Co is recalling bulk enzyme powder that may contain chloramphenicol above permitted limits. The product is distributed domestically and internationally.

    Product
    Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419);
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0837-2014·2013-12-25

    Nature's Way Men's Ultra Potency Tablets Recalled for Chloramphenicol

    Schwabe North America is voluntarily recalling Nature's Way Alive Once Daily Men's Ultra Potency tablets because the raw material supplier reported the enzyme blend may contain the antibiotic chloramphenicol.

    Product
    Nature's Way,UPC 33674156858, Alive Once Daily Men's Ultra Potency, 60 Tabs, 20010553, 20012800
    Category
    Food
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0544-2014·2013-12-25

    SpineFrontier Recalls PedFuse Reset Pedicle Screws Due to Assembly Error

    SpineFrontier, Inc. is recalling 35 PedFuse Reset pedicle screws because one unit was found assembled with the wrong size screw. The recall covers devices distributed to Virginia and Texas.

    Product
    PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0743-2014·2013-12-25

    National Enzyme Recalls Supergest Capsules Due to Potential Chloramphenicol Contamination

    National Enzyme Co is recalling 1.7 million Supergest bulk capsules because they may contain chloramphenicol above the 0.3 ppb limit.

    Product
    4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0814-2014·2013-12-25

    National Enzyme Recalls Dietary Supplements for Potential Chloramphenicol Contamination

    National Enzyme Co is recalling bulk dietary supplement powders that may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453); (2) Bulk Bision Isolase…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0780-2014·2013-12-25

    National Enzyme Co Recalls Gluten & Dairy Digest Due to Chloramphenicol

    National Enzyme Co is recalling specific lots of Gluten & Dairy Digest enzyme supplements because they may contain chloramphenicol above 0.3 ppb.

    Product
    Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO;
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2014·2013-12-25

    Biomet Recalls CurvTek Eye Needles Due to Incorrect Inner Labeling

    Biomet, Inc. is recalling 21 CurvTek Eye Needles because the inner label incorrectly identifies the product size and reference number.

    Product
    outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0742-2014·2013-12-25

    National Enzyme Recalls Wellzymes Gastric Ease Due to Chloramphenicol

    National Enzyme Co is recalling Wellzymes Gastric Ease enzyme supplements because a raw material may contain chloramphenicol levels above 0.3 ppb.

    Product
    WELLZYMES, Gastric Ease, Enzyme Supplement packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0843-2014·2013-12-25

    Nature's Way Recalls Alive No Iron Tablets Due to Chloramphenicol Risk

    Nature's Way is voluntarily recalling Alive No Iron tablets because the raw material supplier reported that enzymes in the blend may contain the antibiotic chloramphenicol.

    Product
    Alive No Iron (for international sales), 30 Tabs HDPE Bottle in a Box 12
    Category
    Drug
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0542-2014·2013-12-25

    CooperVision Recalls Pro Clear 1 Day Sphere Contact Lenses for Incorrect Expiry Dates

    CooperVision is recalling 153 cartons of Pro Clear 1 Day Sphere contact lenses because the outer cartons display incorrect expiration dates, although the inner blisters are correct.

    Product
    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2014·2013-12-25

    Qualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for…
    Category
    Medical Device
    Distribution
    16 states

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