The Recall Desk

Archive

April 2015 recalls

1,319 recalls were announced in April 2015.

What the numbers show

Critical
109
Severe
527
High
388
Moderate
278
Low
17

Of the 1,319 recalls this month scored against our rubric, 8% are Critical, 40% are Severe.

Which agencies issued them

801–900 of 1319

  • SevereFDA (Food)·F-1919-2015·2015-04-15

    Kirsch Mushroom Co. Recalls Imported Dry Mushrooms for Undeclared Sulfites

    Kirsch Mushroom Co. Inc. is recalling 495 lbs of imported dry mushrooms sold in New York due to undeclared sulfites.

    Product
    IMPORTED DRY MUSHROOMS, bulk box 30 lbs, distributed by Kirsch Mushroom Co. Inc., 751 Drake St., Bronx, NY 10474 (labeling for bulk product not provided by NYSDAM) --- Repacked product: IMPORTED DRY MUSHROOMS, WEIGHT XXX - SLOAN SUPERMARKET 494 REIMAN STREET SLOAN, N.Y. 14212 -
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1911-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Organic Spinach Due to Listeria

    Coastal Green Vegetable Company is recalling 398,000 lbs of frozen chopped organic spinach due to Listeria monocytogenes contamination. The product was distributed in California, Oregon, Washington, and Wisconsin.

    Product
    -Frozen IQF ¿ Chopped Organic Spinach Packed in Bulk in 1,000 lb tote bins Each tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 143193006
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·15V223000·2015-04-15

    Chrysler Recalls 2015 Ram ProMaster City for Side Air Bag Defect

    Chrysler is recalling 2015 Ram ProMaster City vehicles because side air bag curtains may not deploy properly, increasing injury risk in crashes.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1331-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1329-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1916-2015·2015-04-15

    NuSpice Taco Seasoning Recalled for Potential Peanut Contamination

    Nu Products Seasoning Co. is recalling NuSpice Taco Seasoning because it may be contaminated with peanut protein from ground cumin.

    Product
    NuSpice Taco Seasoning - F4422 D, Net Wt: 48 lb packed 8/ 6 lb bags, Manufacturer: Nu Products Seasoning co., 74 Louis Court, South Hackensack, N.J. 07606
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1920-2015·2015-04-15

    Nutiva Coconut Treats Recalled Due to Salmonella Risk

    Nutiva is recalling O'Coconut Lightly Sweetened Coconut Treats because a contract manufacturer found Salmonella in the coconut flakes used to make them.

    Product
    Nutiva O'Coconut Lightly Sweetened Coconut Treat - Classic Sold in 8 - x 0.5 oz. individually wrapped pieces, UPC 6-92752-10557-9 and Singles of 24 - 0.5 oz, per box - UPC 6-92752-10500-5. - 24 singles x 6 caddies per shipping case - 144 individual units. Certified Organic, F
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1929-2015·2015-04-15

    Classic Cooking Kale and Quinoa Cake Recalled for Undeclared Peanut

    Classic Cooking LLC is recalling Kale and Quinoa Cake because it contains undeclared peanut protein, a major allergen.

    Product
    classic cooking Kale and Quinoa Cake, NET WT. 6.75 lbs. UPC 7-4863-32511-8. KEEP FROZEN.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1931-2015·2015-04-15

    Giant Eagle Little Italy Panini Recalled for Undeclared Egg

    Giant Eagle is recalling Little Italy Panini products containing undeclared egg. Consumers with these items should not eat them.

    Product
    Packed in rigid plastic clam shell container: Giant Eagle Little Italy Panini Cold; Sell By: (all dates up to and including) 3/24/2015; PLU #97525; Net Wt 13oz; Contains Wheat, Milk, Fish (Anchovy); Keep Refrigerated ; Giant Eagle Little Italy Panini Hot; Sell By: (all dates u
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1904-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling 1,440 lbs of Coastal Harbor smoked salmon because samples tested positive for Listeria monocytogenes.

    Product
    Oak and Beechwood smoked salmon under the following brand; Coastal Harbor SKU: 8 30859 01440 4 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0431-2015·2015-04-15

    Navinta Recalls Fomepizole Injection Due to Sterility Assurance Concerns

    Navinta LLC is recalling Fomepizole Injection due to FDA inspection findings of GMP violations that may impact sterility. The recall covers 14,628 units distributed nationwide.

    Product
    Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1912-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Organic Spinach for Listeria

    Coastal Green Vegetable Company is recalling 74,000 lbs of frozen organic spinach due to Listeria monocytogenes contamination.

    Product
    -Frozen IQF Cut Leaf Organic Spinach Packed in Bulk in 1,000 lb tote bins Each tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 1431930067
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1902-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of Oakwood smoked salmon because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Oakwood smoked salmon mild under the following brands; Cambridge House SKU: 8 30859 01079 6, Grade A Trimmings SKU: 8 30859 02484 7 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • SevereNHTSA·15V225000·2015-04-15

    GM Recalls 2004-2007 Cadillac CTS-V for Brake Hose Corrosion

    General Motors is recalling 2004-2007 Cadillac CTS-V vehicles in specific states because front brake hose fittings may corrode, potentially causing brake leaks and increased stopping distance.

    Product
    CADILLAC — CADILLAC CTS-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1915-2015·2015-04-15

    Giant Eagle Irish Soda Bread Recalled for Undeclared Milk Allergen

    Giant Eagle is voluntarily recalling Irish Soda Bread due to an undeclared milk allergen discovered after a customer complaint of an allergic reaction.

    Product
    Giant Eagle Irish Soda Bread, 16oz loaf, in plastic wrap, one 16oz loaf per wrapped package
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1377-2015·2015-04-15

    Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent

    Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.

    Product
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-1914-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Spinach Due to Listeria Contamination

    Coastal Green Vegetable Company is recalling 30,800 lbs of frozen chopped spinach because testing confirmed the presence of Listeria monocytogenes.

    Product
    -Frozen IQF 1/2 Chopped Spinach Packed in Bulk in 40 lb cases Each case is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 1431930067 Quantity: 1 Net
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1932-2015·2015-04-15

    Arcadia Trading Recalls Uneviscerated Red Thread Fish

    Arcadia Trading is recalling Red Thread Fish found to be uneviscerated. The product was distributed in seven states.

    Product
    RED THREAD FISH, NET WT: 7 OZ (200g), UPC 6 946976 817904, PRODUCT OF MYANMAR -- PACKED FOR; S W TRADING CO. HONG KONG --- The product was packed in a heat-sealed plastic bag.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1913-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Spinach Due to Listeria

    Coastal Green Vegetable Company is recalling frozen chopped spinach and cut leaf spinach due to the presence of Listeria monocytogenes.

    Product
    -Frozen IQF Conventional Chopped Spinach Packed in Bulk in 1,000 lb tote bins or 40 lb cases Each case and/or tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinac
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1880-2015·2015-04-15

    Texamerican Turkey Taco Seasoning Recalled for Peanut Allergen Contamination

    Texamerican Food Blending is recalling 47-pound bags of GF Turkey Taco Seasoning because two lots of ingredients were contaminated with peanut allergen, which is not listed on the label.

    Product
    Texamerican GF Turkey Taco Seasoning 47 lbs. Item Number 1405004
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1918-2015·2015-04-15

    Nicomex Candy Mex Candy Coated Nuts Recalled for Allergen Mislabeling

    Nicomex Inc. is recalling Candy Mex Candy Coated Nuts because the product contains undeclared almonds and peanuts and lacks an ingredient label.

    Product
    Nicomex Candy Mex, Productos Mexicanos, Distributed by Nicomex, Inc., 88 First Street, Passaic, NJ 07055
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1887-2015·2015-04-15

    Seattle Pops Coconut Cream Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Coconut Cream Frozen Pops because they contain an ice cream ingredient potentially contaminated with Listeria monocytogenes.

    Product
    Coconut Cream Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***cream, milk, skim milk powder, non-gmo cane sugar, coconut milk, coconut flakes, less than 0.4% stabilizer (carob bean gum, guar gum,
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0434-2015·2015-04-15

    Wallcur Recalls Practi-0.9% Sodium Chloride Bags Due to Non-Sterility

    Wallcur Incorporated is recalling Practi-0.9% Sodium Chloride bags because they were manufactured in a non-sterile facility and are not intended for human or animal use.

    Product
    Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-481-2015·2015-04-15

    Baxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments

    Baxter Healthcare is recalling 542,080 bags of 0.9% Sodium Chloride Injection USP due to confirmed reports of blue plastic fragments from vial adapters.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1885-2015·2015-04-15

    Seattle Pops Pumpkin Pie Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Pumpkin Pie Frozen Pops due to potential Listeria monocytogenes contamination from an ice cream ingredient.

    Product
    Pumpkin Pie Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***pumpkin, cinnamon, cloves, nutmeg, cream, milk, skim milk powder, non-gmo cane sugar, less than 0.4% stabilizer (carob bean gum, guar g
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1889-2015·2015-04-15

    Seattle Pops Chocolate Sea Salt Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Chocolate Sea Salt Frozen Pops due to potential Listeria monocytogenes contamination from an ice cream ingredient.

    Product
    Chocolate Sea Salt Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***cream, milk, skim milk powder, non-gmo cane sugar, bittersweet chocolate (chocolate liquor, sugar, cocoa, butter, soy lecithin,
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1404-2015·2015-04-15

    Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems

    Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.

    Product
    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Food)·F-1936-2015·2015-04-15

    AI Foods Recalls Cheesetix Cheese Lumpia for Undeclared Wheat

    AI Foods is recalling Cheesetix (Cheese Lumpia) 12.6 oz due to undeclared wheat. The product was distributed in eight US states.

    Product
    Cheesetix (Cheese Lumpia) 12.6 oz, 20 units/case, UPC 0 30283 16542 4
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1394-2015·2015-04-15

    Toshiba INFX-8000V Interventional Angiography System Recall for Brake Defect

    Toshiba is recalling 28 INFX-8000V Interventional Angiography Systems because the table base rotational brake may not engage when force is applied to the table top.

    Product
    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1937-2015·2015-04-15

    AI Foods Recalls Lumpia Vegetable with Shrimp for Undeclared Wheat

    AI Foods is recalling Lumpia Vegetable with Shrimp due to undeclared wheat. The product was distributed in eight states.

    Product
    Lumpia Vegetable with Shrimp, Net Wt. 20 oz., 12 units/case, UPC 0 30283 15027 7, UPC 0 30283 16397 0.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1380-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Arm Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.

    Product
    da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1382-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1941-2015·2015-04-15

    Iberia Sazon Seasoning Recalled for Undeclared Peanut Protein

    Iberia Foods is recalling Sazon Iberia seasoning because it may contain undeclared peanut protein. Consumers should check lot numbers and stop using the product.

    Product
    SAZON IBERIA CON CULANTRO Y ACHIOTE Coriander & Annatto: 1) NET WT. 3.52 OZ. 100g, 18/20 PACKS, UPC 0 75669 10832 9, 2) NET WT. 6.34 OZ. 180g, 15/36 PACKS, UPC 0 75669 10831 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·15110·2015-04-15

    Husky Vertical Bike Hooks Recalled Due to Risk of Injury

    Waterloo Industries is recalling Husky Securelock Vertical Bike Hooks because they can detach and fall, posing a risk of injury to bystanders.

    Product
    Husky® Securelock™ Vertical Bike Hooks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1921-2015·2015-04-15

    Nutiva Coconut Treats Recalled Due to Salmonella Contamination in Coconut Flakes

    Nutiva is recalling O'Coconut Lightly Sweetened Coconut Treats because desiccated coconut flakes used in the product tested positive for Salmonella.

    Product
    Nutiva O'Coconut Lightly Sweetened Coconut Treat - Hemp & Chia. Sold in Singles of 24 - 0.5 oz, per box - 6-92752-10502-9 24 singles x 6 caddies per shipping case - 144 individual units per case. Certified Organic, Fair Trade Certified. Manufactured for: Nutiva, 213 W. C
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1935-2015·2015-04-15

    AI Foods Recalls Cheesetix Pimiento for Undeclared Wheat

    AI Foods is recalling Cheesetix (Cheese Lumpia) Pimiento because the product contains undeclared wheat, a major food allergen.

    Product
    Cheesetix (Cheese Lumpia) Pimiento (12.6 oz), 20 units/case, UPC 0 30283 16529 5
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1400-2015·2015-04-15

    Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks

    Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.

    Product
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1389-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1386-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1942-2015·2015-04-15

    Vitarroz Sazon Seasoning Recalled for Undeclared Peanut Protein

    Iberia Foods is recalling Vitarroz Sazon seasoning packets because the cumin ingredient may contain undeclared peanut protein.

    Product
    VITARROZ SAZON CON CULANTRO Y ACHIOTE CORIANDER & ANNATTO, NET WT. 6.34 OZ. 180g, Jumbo SOBRES 36 PACKETS, UPC 0 72670 04255 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1892-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Brown/Crunch Sold in Single size and 3 pack and Halloween. Ingredients: Fresh Selected Apples, Sugar, Water, Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil,Peanuts and/or corn and soy cereal parts, flour, salt,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1381-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1891-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc. is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Red/Peanuts. Sold in Single size and 3 pack (12 oz. (340g) and Halloween. Ingredients: Fresh Selected Apples, Peanuts, Sugar, Water, Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil,Peanuts and/or corn and soy ce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0483-2015·2015-04-15

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers vials distributed nationwide and internationally.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1906-2015·2015-04-15

    Myc Ingredients Recalls Ground Cumin for Undeclared Peanut Protein

    Myc Ingredients is recalling 1,918 pounds of ground cumin distributed in New Jersey and New York because it may contain undeclared peanut protein.

    Product
    MYC Ingredients, Inc. Ground Cumin-ETO treated, NET WT 50 LBS. DISTRIBUTED BY: MYC Ingredients 718-793-3310
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1925-2015·2015-04-15

    Mamma-Italia Pizza Dough Recalled for Undeclared Milk Allergen

    Dough Acquisition Co is recalling Mamma-Italia pizza dough balls because the labels fail to declare milk as an ingredient.

    Product
    Gourmet Foods Mamma-Italia WHOLE GRAIN WHITE WHEAT Raw Pizza Dough Ball, Box Quantity: 12, 22 oz Ball Keep Frozen NET WT: 16.5 lbs (7.484 Kg), Ingredients: Whole Wheat Flour***Dough Conditioner (Whey, Corn Flour***). Mamma_Italia Brunswick OH 866.368.4446 MAMMA-ITALIA.COM 8 9554
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1934-2015·2015-04-15

    AI Foods Recalls Lumpia Vegetable for Undeclared Wheat

    AI Foods is recalling Lumpia Vegetable products due to undeclared wheat, a major food allergen. The recall affects 54 units distributed across eight US states.

    Product
    Lumpia Vegetable (20 oz), 12 units/case, UPC 0 30283 16272 0
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·15V222000·2015-04-15

    Chrysler Recalls 2006 Dodge Viper and Jeep Models for Clutch Defect

    Chrysler is recalling 2006 Dodge Viper and Jeep Wrangler/Liberty vehicles because a broken clutch pedal spring may cause the vehicle to lurch unexpectedly, increasing crash risk.

    Product
    DODGE — DODGE, JEEP VIPER COUPE, LIBERTY, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1330-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1393-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Vision-Cart Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1378-2015·2015-04-15

    Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent

    Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.

    Product
    CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic su
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-1893-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Red/Crunch Sold in Single size and 3 pack and Halloween. Ingredients: Fresh Selected Apples, Sugar, Water, Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil,Peanuts and/or corn and soy cereal parts, flour, salt, l
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0482-2015·2015-04-15

    Hospira Recalls Ketorolac Tromethamine Injection Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection because of crystallization. The affected vials were distributed nationwide and in Guam and Singapore.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1900-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Mild Smoked Citron Vodka sliced side under the following brand; Cambridge House SKU: 8 30859 01115 1 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smoked salmon
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·F-1923-2015·2015-04-15

    Talenti Sea Salt Carmel Gelato Recalled for Unlabeled Peanut Ingredient

    Unilever is recalling specific jars of Talenti Sea Salt Carmel Gelato because they may contain peanuts that are not listed on the label.

    Product
    Talenti Gelato & Sorbetto, 1 pt. (473 mL) in clear plastic jars with best by date 5/19/2016, UPC 8685200024
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1924-2015·2015-04-15

    Mamma-Italia Pizza Dough Recalled for Missing Milk Allergen Labeling

    Dough Acquisition Co is recalling Mamma-Italia pizza dough because labels failed to declare milk as an ingredient.

    Product
    Gourmet Foods Mamma-Italia Traditional Italian Raw Pizza Dough Ball, Box Quantity: 30 16 oz BALL Keep Frozen NET WT: 30 lbs (13.61Kg), Ingredients: Wheat Flour***Dough Conditioner (Whey, Corn Flour***). Mamma_Italia Brunswick OH 866.368.4446 MAMMA-ITALIA.COM 8 95548 00213 1
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1335-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1938-2015·2015-04-15

    AI Foods Recalls Seafood Eggrolls Due to Undeclared Wheat

    AI Foods is recalling Seafood Eggroll Lumpiang Shanghai products because they contain undeclared wheat, a major food allergen.

    Product
    Seafood Eggroll Lumpiang Shanghai, Reg. Size 34 oz, 9 units/case, UPC 7 95981 09175 7
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·15V224000·2015-04-15

    Thor Motor Coach Recalls 2016 Motorhomes for Missing Weight Label

    Thor Motor Coach is recalling 168 model year 2016 motorhomes because the Occupant and Cargo Carrying Capacity label may be missing water weight information, creating an overload risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MOTOR CHATEAU, OUTLAW, CITATION, SIESTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15728·2015-04-15

    Cycle Gear Recalls Wheelies Toys Due to Excessive Lead Levels

    Cycle Gear is recalling Wheelies semi-truck and motorcycle toys because they contain excessive lead levels, violating federal standards.

    Product
    Wheelies semi-truck with six motorcycles and push-along motorcycle with rider.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1933-2015·2015-04-15

    AI Foods Recalls Banana Langka Empanadas for Undeclared Wheat

    AI Foods is recalling Banana Langka Empanadas due to undeclared wheat, a major allergen. The product was distributed in eight US states.

    Product
    Banana Langka Empanada (6.5 oz), 24 units/case, UPC 0 30283 16483 0
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1939-2015·2015-04-15

    AI Foods Recalls Ube Macapuno Empanadas for Undeclared Wheat

    AI Foods is recalling Ube Macapuno Empanadas because they contain undeclared wheat, a major food allergen.

    Product
    Ube Macapuno Empanada, Net Wt. 6.5 oz, 24 units/case Net Wt. 6.5 oz., UPC 0 30283 16482 3
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1385-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Head Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1397-2015·2015-04-15

    CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date

    CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.

    Product
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2015·2015-04-15

    Siemens QuikLYTE Dilution Check Recalled for Potential Result Bias

    Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.

    Product
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE modul
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1399-2015·2015-04-15

    Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error

    Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.

    Product
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1396-2015·2015-04-15

    Bacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors

    Bacterin International is recalling 63 Instrument Kits for OsteoSponge SC grafts because the instructions for use contain incorrect sterilization parameters.

    Product
    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instrumen
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1379-2015·2015-04-15

    TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling

    TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1332-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0484-2015·2015-04-15

    RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization

    RemedyRepack Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The affected vials were distributed in Pennsylvania and Oklahoma.

    Product
    KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1388-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects

    Intuitive Surgical is recalling da Vinci S/Si Camera Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1383-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes

    Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1334-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1387-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects

    Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1328-2015·2015-04-15

    Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1922-2015·2015-04-15

    Nutri-Dyn Recalls 5-HTP Extra Strength Capsules Due to Mislabeling

    Nutri-Dyn Midwest, Inc. is recalling 5-HTP Extra Strength dietary supplements because bottles were mistakenly labeled during CoQ-10 production.

    Product
    Nutri-Dyn, 5-HTP Extra Strength, Pharmaceutical Grade from Switzerland, Dietary Supplement 60 capsules in plastic bottle, 5-Hydroxytryptophan (5-HTP) 200 mg., Other Ingredients: Rice flour, magnesium stearate, and silica, UPC # 6 96859 02947 9, Sku # R200E.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1391-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

    Product
    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0436-2015·2015-04-15

    Heritage Pharmaceuticals Recalls Gliptizide and Metformin Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling specific lots of Gliptizide and Metformin HCL tablets because they failed impurity specifications. The affected bottles were distributed nationwide.

    Product
    GLIPIZIDE AND METFORMIN HCL — GLIPIZIDE AND METFORMIN HCL (GLIPIZIDE AND METFORMIN HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·062-2015·2015-04-15

    B & R Meat Processing Recalls Pork Products Due to Excess Nitrite Levels

    B & R Meat Processing is recalling approximately 569 pounds of cured pork products because nitrite levels exceeded regulatory limits. No adverse reactions have been reported.

    Product
    B & R Meat Processing — B & R Meat Processing, Inc. Recalls Products Due to Nitrite Levels in Excess of Regulatory Limit
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1408-2015·2015-04-15

    VasoNova Vascular Positioning System G4 Console Recalled for Standard Noncompliance

    VasoNova is recalling 17 Vascular Positioning System G4 Consoles due to noncompliance with IEC Standard 60101-1-1.

    Product
    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1402-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P640 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P640 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1333-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D00432-2015·2015-04-15

    Qualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity

    Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup because a stability lot failed impurity specifications.

    Product
    PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0435-2015·2015-04-15

    Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.

    Product
    Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1403-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P641 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1401-2015·2015-04-15

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P635 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended organism.

    Product
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • SevereUSDA FSIS·061-2015·2015-04-14

    Beech-Nut Recalls Baby Food Jars Due to Possible Glass Contamination

    Beech-Nut Nutrition is recalling approximately 1,920 pounds of Stage 2 sweet potato and chicken baby food jars due to possible glass contamination.

    Product
    Beech-Nut Nutrition Corporation — Beech-Nut Nutrition Recalls Baby Food Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V219000·2015-04-14

    Gillig Recalls 2013-2015 Low Floor Buses Due to Brake Hose Wear

    Gillig is recalling 623 Low Floor transit buses from 2013-2015 because brake hoses may rub against suspension towers, potentially causing air leaks and increased stopping distances.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15109·2015-04-14

    San Pedro Manufacturing Recalls Renovated Mattresses and Foundations

    San Pedro Manufacturing is recalling about 4,800 renovated mattresses and foundations because they fail to meet federal fire safety standards.

    Product
    Mattresses and Mattresses with Foundations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·060-2015·2015-04-13

    Leader Slaughterhouse Recalls Veal Carcasses Produced Without Full Federal Inspection

    Leader Slaughterhouse, LLC is recalling approximately 1,800 pounds of veal carcasses produced without the full benefit of federal inspection. The product was distributed to customers in Pennsylvania and New York.

    Product
    Leader Slaughterhouse, LLC — Leader Slaughterhouse, LLC Recalls Veal Carcasses Produced Without Full Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V215000·2015-04-13

    Crossroads Recalls 2016 Recreational Trailers Due to Wheel Stud Defect

    Crossroads is recalling 2016 recreational trailers because wheel studs may break, potentially causing the wheel to detach and increasing crash risk.

    Product
    CROSSROADS — CROSSROADS LONGHORN REZERVE, Z1, ELEVATION, HAMPTON
    Category
    Vehicle
    Distribution
    Distributed nationwide

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