We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.
FDA and EPA issue final fish consumption advice
Today, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency issued final advice regarding fish consumption. This advice is geared toward helping women who are pregnant or may become pregnant – as well as breastfeeding mothers and parents of young children – make informed choices when it comes to fish that are healthy and safe to eat. (This advice refers to fish and shellfish collectively as “fish.”)
Blue Ridge Beef Recalls Product Because of Possible Health Risk
Blue Ridge Beef is voluntarily recalling one (1) of its frozen products due to their potential to be contaminated with Listeria monocytogenes. Listeria can affect animals eating the product. There is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surface exposed to these products.
Blue Ridge Beef Recalls Product Because of Possible Health Risk
Blue Ridge Beef is voluntarily recalling one (1) of its frozen products due to their potential to be contaminated with Listeria monocytogenes. Listeria can affect animals eating the product. There is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surface exposed to these products.
The Pictsweet Company Announces Voluntary Recall of Pictsweet Farms 12oz Breaded Okra due to Risk of Glass Contamination
The Pictsweet Company is voluntarily recalling select packages of Pictsweet Farms 12 ounce Breaded Okra after the company learned that some packages may contain glass fragments, which could cause injury if ingested. There has been one minor injury reported in connection with this issue.
Grange Co-Op Recalls Rogue All Purpose Rabbit Pellets For High Vitamin D Health Risk
Grange Co-op is initiating a recall of Rogue All Purpose Rabbit Pellets in 25# (25RP) 50# (50RP), 1,500# Tote (RP) no lot codes- purchased between March 1, 2016 and January 12, 2017 in Southern Oregon / Northern California from any Grange Co-op Retail Store or Wholesale Dealer. The recall is being initiated because samples tested by the Oregon Department of Agriculture discovered these products may contain higher than acceptable levels of vitamin D.
Physio-Control Launches Voluntary Field Action for LIFEPAK 1000 Defibrillator
Physio-Control announced today that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.
Golden Flake Snack Foods, Inc., Announces Voluntary Recall of Two Specific Product Code Lots of HOT Thin & Crispy 5.0 oz. Potato Chips Due to Possible Health Risk
Birmingham, AL: Golden Flake Snack Foods, Inc., is voluntarily recalling a limited quantity of 5 oz. HOT Thin & Crispy Potato Chips with a “Best if Used By” date APR 1417 and Specific Product Code Lot 364 5 or 365 5 (See below).
Hy-Vee Voluntarily Recalls Several Candy Products Due to Possible Health Risk
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling several candy trays because they have the potential to be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention when Palmer Candy Company announced a limited recall of certain chocolate products after it was informed by its supplier, Valley Milk Products LLC, that a milk powder ingredient used in a compound chocolate coating has the potential to be contaminated with Salmonella.
Read The Complete Story!
Dutch Valley Food Distributors, Inc. Announces a Voluntary Nationwide Recall of Cappuccino Snack Mix For Potential Salmonella
As a result of an ingredient supplier recall, Dutch Valley is issuing a recall on Cappuccino Snack Mix due to the potential for it to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.