FDA Enforcement and Recall Report Week of June 6
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.
FDA Recalls – Allergen Recalls
Recall postings picked up steam again this past week. After only three new recall postings preceding the Memorial Day holiday a full 23 recall postings this past week. It appears Listeria is continuing to drive the number of recalls – a full 16 of the 23 notices involved Listeria. This is likely still tied to the CRF recall. As the CRF recall continues to cool – this week will provide evidence of how many recalls remain – expect to see allergen recalls swing back to the top. Undeclared allergens are traditionally the top reason for recalls. That will change as FSMA goes into effect – the FDA is requiring all allergens be declared or properly controlled under the HARPC rule.
Also note the recall for insufficient pasteurization. As FSMA goes into effect it will not be enough to simply note a supplier pasteurizes a product, but to ensure that process is validated and adequately controlling the risk. This type of recall will soon have FSMA implications!
FDA Warning Letters
FDA Warning Letters post weekly but generally are issued earlier than posted. There were no new Warning Letters. This post will be amended when the latest Warning Letters are added.
Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.
|06/04/2016||MaraNatha||Sunflower Seed Butter||Listeria monocytogenes||MaraNatha|
|06/04/2016||PediaSmart||Dairy Vanilla complete nutrition beverage powder packaged in 12.7 ounce cans||Possible under-delivery of nutrition using included scoop||Nature’s One|
|06/03/2016||Mountain Thins||Trail Mix||Listeria monocytogenes||Brown & Haley|
|06/03/2016||Hostess||Snack cakes, donuts||Undeclared peanut||Hostess Brands LLC|
|06/03/2016||Kashi, Bear Naked||Snack bars, granola, granola bars||Listeria monocytogenes||Kashi Company|
|06/03/2016||Jarlsberg||Cheese spread, cookies and cream dessert||Undeclared eggs||Chelsea Food Services|
|06/03/2016||Hickory Harvest, IM Good, Sheetz, and others||Sunflower Kernels||Listeria monocytogenes||Hickory Harvest Foods|
|06/03/2016||Bayou Brothers||Creole sauce||Undeclared fish||Bayou Brothers|
|06/03/2016||Hy-Vee||Salad topping, trail mix, trail mix bars, protein bars||Listeria monocytogenes||Hy-Vee, Inc.|
|06/03/2016||Alpine Valley, Wegmans, Flave Fitness, Gonzo, more||Products containing sunflower kernels||Listeria monocytogenes||First Source|
|06/02/2016||Clif and Clif Bar||Energy bars, trail mix bars||Listeria monocytogenes||Clif Bar & Company|
|06/02/2016||Jungle Jim, Windy Acres||Sunflower seeds, trail mix||Listeria monocytogenes||Windy Acres Candy & Nut Company|
|06/02/2016||Quaker||Quinoa granola bars||Listeria monocytogenes||The Quaker Oats Company|
|06/02/2016||Sun Life||Sunflower spreads||Listeria monocytogenes||Nu Life Market|
|06/02/2016||Durkee, Food Club, Hy-Vee||Salad toppings||Listeria monocytogenes||ACH Food Companies, Inc.|
|06/02/2016||Bybee’s,Columbia River Organics, Northwest Growers Select and others||Frozen Organic and Traditional Fruits and Vegetables||Listeria monocytogenes, CRF2016||CRF Frozen Foods|
|06/01/2016||Various: Sunrich, Spitz, Navitas Natural, Planters, Kar’s||Sunflower kernels||Listeria monocytogenes||SunOpta Inc.|
|06/01/2016||Frontera||Frontera||Undeclared Soy||Frontera Foods|
|06/01/2016||Publix||Nut, Seed and Raisin mix||Listeria monocytogenes||Publix Super Markets|
|06/01/2016||Meadow Gold||Whipping cream and Half & Half||Insufficient pasteurization||Meadow Gold Dairy|
|05/31/2016||Kashi and Bear Naked||Granola Bars, Granola||Listeria monocytogenes||Kashi Company|
|05/31/2016||Backroad Country||Cranberry Nut Delight Mix, Honey Island Crunch Mix, Peanut Butter Pretzels, Walnuts Halves & Pieces, Sun Flower seeds||Listeria monocytogenes||Troyer® Cheese Inc.|
|05/31/2016||Gold Medal, Gold Medal Wondra, Signature Kitchens||Flour||E.coli||General Mills|
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