The Recall Desk

Archive

May 2015 recalls

653 recalls were announced in May 2015.

What the numbers show

Critical
52
Severe
145
High
352
Moderate
90
Low
14

Of the 653 recalls this month scored against our rubric, 8% are Critical, 22% are Severe.

Which agencies issued them

201–300 of 653

  • HighFDA (Food)·F-2199-2015·2015-05-20

    Corn Maiden Foods Recalls Border Grill Tortilla Soup for Undeclared Soy

    Corn Maiden Foods is recalling Border Grill Tortilla Soup because it contains undeclared hydrolyzed soy protein. The product was distributed to one restaurant in Los Angeles.

    Product
    Border Grill Tortilla Soup Item # BOR-010, 3 x 8 lbs bags/case with Lot Codes Numbers between 140409 and 150311 Corn Maiden Foods, Inc. 24201 Frampton Av. Harbor City, CA 90710 LOT # Expiration Date Frozen: Expiration After Thaw: 7 days Border Grill Tortilla Soup I
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2274-2015·2015-05-20

    Terra Spice Company Recalls Italian Seasoning for Undeclared Milk Allergen

    Terra Spice Company is voluntarily recalling Italian Seasoning with Romano because the label lists Romano cheese but does not specifically declare milk.

    Product
    Terra Spice Company Italian Seasoning w/ romano (dry spice mix), New Kitchen Store Italian seasoning w/ romano (dry spice mix), Regal Rabbit Italian seasoning w/ romano (dry spice mix), Sawyer Home & Garden Center Italian seasoning w/ romano),SPICE MERCHANTS Italian seasoning w/
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2200-2015·2015-05-20

    KT's Energy Bars Recalled for Undeclared Soy Lecithin

    Taylor Catering, LLC is recalling KT's Energy Bars due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    KT's Energy Bars, net weight per bar is 2.9 oz (82.21 g).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2275-2015·2015-05-20

    Terra Spice Company Recalls Buffalo Wing Rub for Undeclared Allergens

    Terra Spice Company is voluntarily recalling Buffalo Wing Rub because the label fails to declare soy and wheat.

    Product
    Terra Spice Company buffalo wing rub (dry spice mix). Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2230-2015·2015-05-20

    Whole Foods Recalls Lentil Dal Burgers Due to Undeclared Peanut

    Whole Foods Market is recalling 2,455 pounds of Lentil Dal Burgers because they contain undeclared peanut protein. The product was sold in 13 states and the District of Columbia.

    Product
    Burger, Lentil Dal UPC/PLU: 26157400000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2276-2015·2015-05-20

    Terra Spice Company Recalls Barbeque Spice Blend for Undeclared Soy

    Greenies LLC is voluntarily recalling multiple barbeque spice blends because the label lists lecithin but does not specifically declare soy.

    Product
    Terra Spice Company barbeque spice blend (dry spice mix), New Kitchen Store barbeque spice blend (dry spice mix), Sawyer Home & Garden Center barbeque spice blend, WILD ONION Spice Company barbeque spice blend. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, an
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2201-2015·2015-05-20

    KT's Energy Bars Recalled for Undeclared Soy Lecithin

    Taylor Catering, LLC is recalling KT's Energy Bars - Dairy Free! due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    KT's Energy Bars - Dairy Free!, net weight per bar is 2.9 oz (82.21 g).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2294-2015·2015-05-20

    Giant Eagle Recalls Rotisserie Lemon Almond Chicken Salad for Undeclared Milk

    Giant Eagle is recalling Rotisserie Lemon Almond Chicken Salad products due to undeclared milk. The recall affects specific units sold in Maryland, Ohio, Pennsylvania, and West Virginia.

    Product
    Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/15; UPC: 55708 90899; Net Wt 16.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/1
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2255-2015·2015-05-20

    Poco Dolce Bittersweet Chocolate Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling Aztec Chili Tile chocolate because milk was missing from the label as an ingredient of butter.

    Product
    Poco Dolce Bittersweet Chocolate: Aztec Chili Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Pumpkin Seeds, Cinnamon, Ground Chiles, Grey Sea Salt. May
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-2241-2015·2015-05-20

    Whole Foods Mediterranean Salad Bowl Recalled for Undeclared Peanut

    Whole Foods Market is recalling Mediterranean Salad Bowls because they contain undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    Salad, Bowl, Mediterranean UPC/PLU: 00000480502
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2271-2215·2015-05-20

    Terra Spice Company Recalls Jalapeno Cheddar Due to Undeclared Milk

    Terra Spice Company is voluntarily recalling Jalapeno Cheddar dry spice mix because the label lists cheddar and sour cream but does not specifically declare milk.

    Product
    Terra Spice Company Jalapeno Cheddar (dry spice mix). Sold in 0.5, 1, 3, or 5 qt. jars, 6x10 stand up pouches, and bulk up to 50 lbs
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2250-2015·2015-05-20

    Poco Dolce Bittersweet Chocolate Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling Bittersweet Chocolate tiles because milk was missing from the ingredient label. The recall was initiated after a California Department of Public Health inspection.

    Product
    Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Grey Sea Salt. May contain traces of peanuts, tree
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-2210-2015·2015-05-20

    Whole Foods Recalls Tofu Grilled Lime Chipotle for Undeclared Peanut

    Whole Foods Market is recalling Tofu Grilled Lime Chipotle because it contains undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    Tofu Grilled Lime Chipotle UPC/PLU code: 2-31090-00000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2243-2015·2015-05-20

    Whole Foods Adobo Sauce Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling Adobo Sauce for containing undeclared peanut protein. Consumers with peanut allergies should not consume the product.

    Product
    Sauce, Adobo UPC/PLU: 48000011103
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2221-2015·2015-05-20

    Whole Foods Red Beans and Rice Recalled for Undeclared Peanut

    Whole Foods Market is recalling Red Beans and Rice due to undeclared peanut protein. The product was sold in 13 states and Washington, D.C.

    Product
    Red Beans and Rice UPC/PLU: 26193100000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2222-2015·2015-05-20

    Whole Foods Recalls Rub Latin Spice for Undeclared Peanut

    Whole Foods Market is recalling 5-pound bags of Rub Latin Spice because the product contains undeclared peanut protein.

    Product
    Rub Latin Spice 5 LB. UPC/PLU: 48000006317
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2209-2015·2015-05-20

    Whole Foods Recalls Slaw Kale Avocado Salad Due to Undeclared Peanut

    Whole Foods Market is recalling 14 oz. Slaw Kale Avocado HSH salads because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    Slaw Kale Avocado HSH 14 oz. UPC/PLU code: 0-00000-68899
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2239-2015·2015-05-20

    Whole Foods Black Bean Quesadillas Recalled for Undeclared Peanut

    Whole Foods Market is recalling Black Bean Quesadillas due to undeclared peanut protein. Consumers should not eat the product and should return it to the store.

    Product
    Quesadilla, Black Bean
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2236-3015·2015-05-20

    Whole Foods Tofu Meatloaf Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling HotBar Tofu Meatloaf because it contains undeclared peanut protein. The product was sold in 13 states and the District of Columbia.

    Product
    HotBar, NE Tofu Meatloaf UPC/PLU: 48000088750
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2231-2015·2015-05-20

    Whole Foods Recalls Black Bean Burritos Due to Undeclared Peanut

    Whole Foods Market is recalling Black Bean Burritos because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    Burrito, Black Bean UPC/PLU: 00000480430
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2204-2015·2015-05-20

    Aleia's Parmesan Croutons Recalled for Potential Peanut Contamination

    Aleias Gluten Free Foods LLC is recalling Aleia's Parmesan Croutons because the cumin used in manufacturing may contain peanut protein.

    Product
    Aleia's Parmesan Croutons, Gluten Free, NET WT 8 oz (226.8g). UPC Code: 8 55930 00162 3, Product is packaged in a brown cardboard box with white text.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2232-2015·2015-05-20

    Whole Foods Shrimp Burritos Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling shrimp burritos because they contain undeclared peanut protein, posing a risk to individuals with peanut allergies.

    Product
    Burrito, Shrimp UPC/PLU: 00000480432
    Category
    Food
    Distribution
    13 states
  • HighNHTSA·15V299000·2015-05-20

    Forest River Recalls Vengeance Trailers for Incorrect Weight Labels

    Forest River is recalling 2014-2016 Vengeance trailers because incorrect certification labels may cause operators to overload the vehicle, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2015·2015-05-20

    Hydroquinone 10% Cream Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Hydroquinone 10% Cream due to quality control issues affecting sterility and stability data.

    Product
    Hydroquinone 10% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighCPSC·15143·2015-05-20

    Electrolux Recalls Kenmore Elite Ranges Due to Fire and Burn Hazards

    Electrolux is recalling about 250 Kenmore Elite dual fuel ranges sold at Sears because the burner flame can go out while gas is on, posing fire and burn risks.

    Product
    Sears Kenmore Elite dual fuel ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1062-2015·2015-05-20

    Hydrocortisone Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Hydrocortisone 1.6 mg/0.5 mL Suspension due to quality control issues affecting sterility and stability.

    Product
    Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1608-2015·2015-05-20

    Spacelabs qube Compact Monitor Recalled for Power Failure Risk

    Spacelabs Healthcare is recalling five qube Compact Monitors because the input power can fail or the device may not turn on.

    Product
    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric dis
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1613-2015·2015-05-20

    Handicare ReTurn Patient Transfer Belt Recalled for Torn Seams

    Handicare USA is recalling 64 units of ReTurn patient transfer belts because the heat-welded seam on the strap tore when force was applied.

    Product
    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1602-2015·2015-05-20

    Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS07 REF 414 967, Fungal 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 clinically significant yeasts to antifungal agents when used as instr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1036-2015·2015-05-20

    Levodopa 250 mg Capsules Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Levodopa 250 mg NSR Capsules due to quality control issues affecting sterility and stability data.

    Product
    Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1061-2015·2015-05-20

    Nystatin Suppositories Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Nystatin 50,000 Units Suppositories due to quality control issues affecting sterility and stability.

    Product
    Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1023-2015·2015-05-20

    Boric Acid Vaginal Capsules Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Boric Acid Vaginal Capsules due to quality control issues affecting sterility and stability data.

    Product
    Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1611-2015·2015-05-20

    Fujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements

    Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.

    Product
    FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Drugs)·D-1022-2015·2015-05-20

    Health Innovations Pharmacy Recalls Keto-Gabap-Ketamine Cream Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Keto 10%-Gabap 10%-Ketamine 2% Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2291-2015·2015-05-20

    Giant Eagle Recalls Lemon Almond Chicken Salad Wrap for Undeclared Milk

    Giant Eagle is recalling Lemon Almond Chicken Salad Wraps because they contain undeclared milk. Consumers with this product should not eat it.

    Product
    Lemon Almond Chicken Salad Wrap; Sell By: (up to and including) 04/01/15; UPC: 47235 80499; Net Wt 9.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Packed in rigid plastic.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1040-2015·2015-05-20

    Health Innovations Pharmacy Recalls Azithromycin Rectal Suppositories Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Azithromycin 100 mg Rectal Suppositories because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1000-2015·2015-05-20

    Cyanocobalamin Injection Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Cyanocobalamin 2000mcg/1ml Injection due to inspection findings regarding sterility and stability data.

    Product
    Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2227-2015·2015-05-20

    Whole Foods Recalls Salsa Verde for Undeclared Peanut Protein

    Whole Foods Market is recalling 252 pounds of Salsa Verde because it contains undeclared peanut protein. The product was sold in 13 states and the District of Columbia.

    Product
    Salsa Verde UPC/PLU: 48000011104
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2254-2015·2015-05-20

    Poco Dolce Chocolate Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling bittersweet chocolate tiles because the label failed to list milk as an ingredient from butter.

    Product
    Poco Dolce Bittersweet Chocolate: Ginger Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Ginger, Sugar, Grey Sea Salt. May contain traces of peanuts, tre
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1599-2015·2015-05-20

    FDA Recalls VenaSeal Vascular Closure Systems Due to Sterility Concerns

    The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.

    Product
    VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·15142·2015-05-20

    Kenmore Elite Ranges Recalled for Sharp Trim Laceration Hazard

    Electrolux is recalling Kenmore Elite slide-in ranges sold at Sears because a sharp edge on the stainless steel trim below the control panel can cause cuts.

    Product
    Sears Kenmore Elite slide-in ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1007-2015·2015-05-20

    Health Innovations Pharmacy Recalls Glycerin Eye Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Glycerin 98.5% Opth. Solution because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1034-2015·2015-05-20

    Nortriptyline Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Nortriptyline 10 mg/5 mL Suspension due to inspection findings regarding sterility and stability data.

    Product
    Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2292-2015·2015-05-20

    Giant Eagle Recalls Lemon Almond Chicken Salad Wedge for Undeclared Milk

    Giant Eagle is recalling Lemon Almond Chicken Salad Wedge because it contains undeclared milk. The product was distributed in Maryland, Ohio, Pennsylvania, and West Virginia.

    Product
    Lemon Almond Chicken Salad Wedge; Sell By: (up to and including) 04/01/15; UPC: 67093 20399; Net Wt 7.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Packed in rigid plastic.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1010-2015·2015-05-20

    Health Innovations Pharmacy Recalls Phospholine Iodide Eye Drops

    Health Innovations Pharmacy is recalling Phospholine Iodide 0.03% Opth Drops due to quality control issues affecting sterility and stability.

    Product
    Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2228-2015·2015-05-20

    Whole Foods Recalls Southwest Stuffed Sweets for Undeclared Peanut

    Whole Foods Market is recalling Southwest Stuffed Sweets due to undeclared peanut protein. The products were sold in 13 states and Washington, D.C.

    Product
    Southwest Stuffed Sweets HSH CC UPC/PLU: 28634600000; Southwest Stuffed Sweets HSH FP UPC/PLU: 26066400000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2282·2015-05-20

    Gourmet Kitchen Recalls Spicy Shrimp Chopsticks for Peanut Allergen

    Gourmet Kitchen, Inc. is recalling 394 boxes of Spicy Shrimp Chopsticks because the products may contain peanut protein.

    Product
    Spicy Shrimp Chopsticks 80 PCS S5038 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2211-2015·2015-05-20

    Whole Foods Recalls Tofu Burritos Due to Undeclared Peanut

    Whole Foods Market is recalling specific tofu burritos and tacos because they contain undeclared peanut protein. Consumers with peanut allergies should not eat these products.

    Product
    Burrito Chipotle Lime Tofu UPC/PLU: 2-65293-00000; Burrito Chipotle Lime Tofu Tacos UPC/PLU: 2-83938-00000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2293-2015·2015-05-20

    Giant Eagle Recalls Lemon Almond Chicken Salad Sliders for Undeclared Milk

    Giant Eagle is recalling Lemon Almond Chicken Salad Sliders because they contain undeclared milk, a major food allergen.

    Product
    Lemon Almond Chicken Salad Sliders; Sell By: (up to and including) 04/01/15; UPC: 77183 60299; Net Wt 6.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 2 sliders Packed in rigid plastic.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2208-2015·2015-05-20

    Whole Foods Guacamole Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling guacamole products due to undeclared peanut protein. Consumers with peanut allergies should not consume the product.

    Product
    Guacamole Dip Net Wt. 8 OZ. (.5LB) Distributed By: Whole Foods Market UPC/PLU: 0-36406-30279-0; WFM Dip Guacamole PPK UPC/PLU: 3640630278; Guacamole Bulk CC UPC/PLU: 27013500000 in plastic container
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2216-2015·2015-05-20

    Whole Foods Mediterranean Mezze Snack Pack Recalled for Undeclared Peanut

    Whole Foods Market is recalling Mediterranean Mezze Snack Packs because they contain undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    Mediterranean Mezze Snack Pack Net Wt. 9.5 OZ (268g) Whole Foods Market Kitchens UPC/PLU 036406304329
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2225-2015·2015-05-20

    Whole Foods Recalls Chipotle Adobo for Undeclared Peanut Protein

    Whole Foods Market is recalling 300 quarts of Chipotle Adobo due to undeclared peanut protein. The product was sold in 12 states and D.C. through February 5.

    Product
    Chipotle Adobo UPC/PLU: 48000024753
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2290-2015·2015-05-20

    Giant Eagle Recalls Sourdough Bread for Undeclared Wheat and Soy

    Giant Eagle is recalling Dinner Sourdough Bread sold in Maryland, Ohio, Pennsylvania, and West Virginia due to undeclared wheat and soy allergens.

    Product
    Dinner Sourdough Bread; Sell By: (up to and including) 04/02/15; UPC: 67657 00199; Net Wt 9.0oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2288-2015·2015-05-20

    Giant Eagle Recalls Plain Bagels Due to Undeclared Wheat and Soy

    Giant Eagle is recalling Plain Bagels because they contain undeclared wheat and soy. The recall affects 1,046 units sold in Maryland, Ohio, Pennsylvania, and West Virginia.

    Product
    Plain Bagels; Sell By: (up to and including) 04/02/15; UPC: 67785 30499; Net Wt 22oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2296-2015·2015-05-20

    Giant Eagle Recalls Bulk Candies for Undeclared Soy Lecithin

    Giant Eagle is recalling bulk candies sold in Maryland, Ohio, Pennsylvania, and West Virginia due to undeclared soy lecithin.

    Product
    Starlight Candies Giant Eagle Bulk Candies Bulk Bin tag #63826
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1015-2015·2015-05-20

    Health Innovations Pharmacy Recalls Naltrexone Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Naltrexone 4.5 mg capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2279-2015·2015-05-20

    Gourmet Kitchen Recalls Shrimp Maui for Potential Peanut Allergen

    Gourmet Kitchen, Inc. is recalling Shrimp Maui products because they may contain peanut protein. The recall covers 135 boxes distributed nationwide.

    Product
    Shrimp Maui; Maui Shrimp 100 pcs S5036 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2234-2015·2015-05-20

    Whole Foods Mexican Layer Dip Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling Mexican Layer Dip products due to undeclared peanut protein. Consumers should stop eating the product and return it to the store.

    Product
    Dip, Mexican Layer Large UPC/PLU: 00000480504; Dip, Mexican Layer Small UPC/PLU: 00000480505
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2256-2015·2015-05-20

    Central Market Teriyaki Salmon Jerky Recalled for Undeclared Soy and Wheat

    World Wide Gourmet Foods is recalling Central Market Teriyaki Salmon Jerky because the packaging mislabels the product as smoked salmon jerky, failing to declare soy and wheat allergens.

    Product
    Central Market Teriyaki Salmon Jerky, 3 oz. per plastic retail pouch. The front label is correctly identified as Teriyaki Salmon Jerky, but the back side was mis-labeled as Smoked Salmon Jerky with the UPC 0 41220 34270 9.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2278-2015·2015-05-20

    Gourmet Kitchen Recalls Asparagus Roll Ups for Potential Peanut Allergen

    Gourmet Kitchen, Inc. is recalling Asparagus Roll Ups because the products may contain peanut protein. The recall covers 315 cases distributed nationwide.

    Product
    Asparagus Roll Ups; Asparagus Roll-Up 100 PCS v2002 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2295-2015·2015-05-20

    Giant Eagle Recalls Maryland Style Crab Cakes for Undeclared Fish

    Giant Eagle is recalling Maryland Style Crab Cakes because they contain undeclared fish (anchovies) from Worcestershire sauce.

    Product
    Giant Eagle Maryland Style Crab Cake; Sell By: 04/04/2015; PLU#: 47538; Contains Wheat, Egg, Soy, Milk; Keep Refrigerated; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2213-2015·2015-05-20

    Whole Foods Market Recalls Salsa Fresca Due to Undeclared Peanut

    Whole Foods Market is recalling Salsa Fresca products because they contain undeclared peanut protein. Consumers should check their products and stop using them.

    Product
    Salsa Fresca Net Wt. 8 oz. (.5LB) Whole Foods Market; WFM Salsa Fresca PPK; UPC/PLU: 3640630306; Salsa Fresca Bulk CC UPC/PLU: 26206400000
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2203-2015·2015-05-20

    KT's Energy Bars Recalled for Undeclared Sulfite and Labeling Error

    Taylor Catering, LLC is recalling KT's Energy Bars due to undeclared sulfite and a labeling error regarding nuts.

    Product
    KT's Energy Bars No Nuts/Dairy Free. 2.9 oz./82.21 gram bar packaged in saran wrap
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2273-2015·2015-05-20

    Terra Spice Company Recalls Basil Walnut Pesto Blend for Undeclared Milk

    Terra Spice Company is voluntarily recalling basil walnut pesto blend because the label lists parmesan and romano cheese but does not specifically declare milk.

    Product
    Terra Spice Company basil walnut pesto blend (dry spice mix), SPICE MERCHANTS basil walnut pesto blend. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2277-2015·2015-05-20

    Gourmet Kitchen Recalls Spinach and Goat Cheese Focaccia for Peanut Allergen

    Gourmet Kitchen, Inc. is recalling Spinach & Goat Cheese Focaccia because the product may contain peanut protein, posing a risk to individuals with peanut allergies.

    Product
    Spinach & Goat Cheese Pizza (Focaccia) Mackenzie Limited Spinach & Goat Cheese Focaccia 18 PCS #SGC18 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2238-2015·2015-05-20

    Whole Foods Tofu Meatloaf Recalled for Undeclared Peanut Protein

    Whole Foods Market is recalling Tofu Meatloaf because it contains undeclared peanut protein. The product was distributed in 13 states and the District of Columbia.

    Product
    Meatloaf, Tofu
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2226-2015·2015-05-20

    Whole Foods Recalls Chili Firehouse HSH for Undeclared Peanut

    Whole Foods Market is recalling 193 pounds of Chili Firehouse HSH due to undeclared peanut protein. The product was sold in 13 states and Washington, D.C.

    Product
    Chili Firehouse HSH UPC/PLU: 48000035037
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-1056-2015·2015-05-20

    Lansoprazole Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling all lots of Lansoprazole 3 mg/mL Suspension due to quality control issues affecting sterility and stability.

    Product
    Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1080-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 6,467 units of Olanzapine 10 mg orally disintegrating tablets because the drug is subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1615-2015·2015-05-20

    Siemens Dimension Chemistry Systems Recalled for Non-Standard Power Plugs

    Siemens Healthcare Diagnostics is recalling certain Dimension Integrated Chemistry Systems installed with non-standard power plugs due to a potential electrical hazard.

    Product
    Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1612-2015·2015-05-20

    Fujifilm Synapse Cardiovascular Software Recall for Patient Demographic Mismatch

    Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.

    Product
    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2251-2015·2015-05-20

    Poco Dolce Bittersweet Chocolate Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling bittersweet chocolate tiles because the label failed to list milk as an ingredient from butter.

    Product
    Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Grey Sea Salt. May contain traces of peanuts, tree nuts
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1600-2015·2015-05-20

    Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

    Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

    Product
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1065-2015·2015-05-20

    Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Wash Kits

    Mission Pharmacal is recalling 1,992 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash due to microbial contamination.

    Product
    Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.

    Product
    Vitek 2 AST-YS01 REF 22 108, Fungal 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 clinically significant yeasts to antifungal agents when used as instru
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1607-2015·2015-05-20

    Philips Recalls Nuclear Gamma Cameras Due to Collimator Misalignment

    Philips Medical Systems is recalling 975 nuclear gamma cameras because the collimator exchange carriage and storage cabinet were misaligned.

    Product
    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2287-2015·2015-05-20

    Magic Valley Fresh Frozen Recalls Chopped Spinach Due to Pesticide Residue

    Magic Valley Fresh Frozen, Inc. is recalling various brands of chopped and cut leaf spinach because unapproved pesticide Lambda-Cyhalothrin was found at levels higher than 0.01 ppm.

    Product
    Bountiful Harvest Chopped Spinach, KEEP FROZEN, Net Wt. 3 LBS. (1.36kg), Case with 12; Chopped Spinach (Cheney Brothers) 3 pounds, 12 per case; Essential Everyday Chopped Spinach Net Wt. 10 oz. (283g), 24 per case; Essential Everyday Chopped Spinach Net wt. 16 oz. (1 LB) 454g,
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0995-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2015·2015-05-20

    Carvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Carvedilol 1.25 mg/mL due to quality control issues affecting sterility and stability data.

    Product
    Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-2252-2015·2015-05-20

    Poco Dolce Chocolate Tiles Recalled for Missing Milk Labeling

    Poco Dolce Confections is recalling bittersweet chocolate tiles because milk was not listed as an ingredient on the label.

    Product
    Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Coconut, Grey Sea Salt. May contain traces of p
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-2257-2015·2015-05-20

    Purely Elizabeth Muesli Recalled for Undeclared Sulfur Dioxide

    Natural Foodworks Group is recalling Purely Elizabeth Cranberry Cashew Ancient Grain Muesli because it contains undeclared sulfur dioxide.

    Product
    Purely Elizabeth Cranberry Cashew Ancient Grain Muesli, 10 ounces, packaged in plastic bag sealed into paper cartons, 6 packages per case, Manufactured by Natural Foodworks Group, LLC. Denver, CO
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2206-2015·2015-05-20

    Tastefully Simple Recalls Blackberry Syrup Due to Suspected Mold

    Tastefully Simple is recalling specific lots of Blackberry Syrup because of suspected mold presence in some units.

    Product
    Tastefully Simple, Blackberry Syrup, 12 FL oz ( 360 ml), Item 763905. Ingredients: Corn syrup, blackberries, cane sugar, lemon juice, natural flavor. Container consists of Glass, flask bottle with black boot seal over cap/neck of bottle. These multi-product items also include
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1601-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS06 REF 412 610, Fungal 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 clinically significant yeasts to antifungal agents when used as instruc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1605-2015·2015-05-20

    BioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component

    BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.

    Product
    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2015·2015-05-20

    Stryker Recalls 80 mm Kinemax Stem Extenders Due to Mislabeling

    Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.

    Product
    Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1045-2015·2015-05-20

    Health Innovations Pharmacy Recalls Nifedipine and Lidocaine Jelly

    Health Innovations Pharmacy is recalling Nifedipine 0.2% - Lidocaine 2% Jelly due to sterility and stability concerns. The recall covers all lots distributed in North Carolina.

    Product
    Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0996-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0997-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2015·2015-05-20

    Health Innovations Pharmacy Recalls Phenylephrine Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Phenylephrine 0.5% Solution due to quality control issues that present a risk to sterility and stability.

    Product
    Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1082-2015·2015-05-20

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

    Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1019-2015·2015-05-20

    Health Innovations Pharmacy Recalls DHEA Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1057-2015·2015-05-20

    Health Innovations Pharmacy Recalls Colchicine Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Colchicine 0.6 mg capsules because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1597-2015·2015-05-20

    Spinal Elements Mercury Lordosed Rods Recalled for Missing Traceability Markings

    Spinal Elements, Inc. is recalling 588 Mercury lordosed rods because some lack required product identification markings, interrupting device traceability.

    Product
    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1610-2015·2015-05-20

    Zimmer Hemovac Mini Evacuator Recalled for Missing Instructions for Use

    Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.

    Product
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
    Category
    Medical Device
    Distribution
    8 states

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