The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
Mann Packing Voluntarily Issuing Class 1 Recall Of O Organics Organic Vegetable Tray With Creamy Ranch Dressing Dip Due To Mislabeled Ingredients That May Pose An Allergen Risk
Mann Packing is voluntarily recalling 844 cases of 18 ounce O Organics Organic Vegetable Tray with Creamy Ranch Dressing Dip because the product ingredients label does not identify ingredients that could pose an allergen risk; specifically egg, milk and soy.
JML Ingredients Recalls IQF Cut Green Beans Because Of Possible Health Risk
JML Ingredients, Inc. of East Petersburg, PA is recalling IQF Cut Green Beans, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Kratom seized in California by US Marshals Service
The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.
JM Exotic Foods, Inc. Recalls Ground Turmeric Due to Elevated Levels of Lead
JM Exotic Foods, Inc. is recalling ground turmeric because samples from our supplier were found to contain elevated levels of lead. While the U.S. Food and Drug Administration (FDA) has not set a specific limit on lead in spices, there is a limit of 0.1 PPM in candy.
Grassfields Cheese LLC Issues Nationwide Voluntary Recall Of Certain Cheeses
Coopersville, MI — Out of an abundance of caution, Grassfields Cheese LLC, is conducting a voluntary recall of approximately 20,000 pounds of organic cheeses due to possible contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans.
Grassfields Cheese Recall Affects Select Whole Foods Market Locations; Grocer Recalls Product from Cheese Departments
In response to Grassfields Cheese LLC’s organic cheese recall, Whole Foods Market is voluntarily recalling the product from select stores in the Midwest and South out of an abundance of caution. Grassfields Cheese issued the recall due to possible contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans.
Teva Pharmaceuticals Initiates Voluntary Nationwide Recall of Seven Lots of Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials Due to Potential of Glass Particulate Matter
Teva Pharmaceuticals of North Wales, PA, today announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter.
Sage Products Issues Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
CARY, Ill., USA, July 29, 2016 /PRNewswire/ — Sage Products announced today it is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.
Allergen Alert Expansion: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Peanuts or Almonds
Kwik Trip, Inc. located in La Crosse, WI has expanded their recall of Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of peanuts or almonds. Consumers who are allergic to peanuts or almonds may run the risk of serious or life-threatening allergic reactions if they consume this product.