Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company had issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg.
Country Fresh Recalls Product Because Of Possible Health Risk
Country Fresh, LLC. of Conroe, Texas, is recalling 30,000 cases of various fresh-cut vegetable products (product descriptions attached), because they have 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.
Willis Ocean Inc. Issues Allergy Alert on Undeclared Sulfites in Willis Eagle Brand Mut Gung Sweetened Ginger
Willis Ocean Inc. of Brooklyn, NY, is recalling 30 cases of Willis Eagle brand MUT GUNG SWEETENED GINGER, because it contains undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA advises testing for Zika virus in all donated blood and blood components in the US
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
FDA advises testing for Zika virus in all donated blood and blood components in the US
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to raw scallops.
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to raw scallops.
Baptista’s Bakery Issues Allergy Alert on Undeclared Milk in Snack Factory® Original Pretzel Crisps®
Baptista’s Bakery, Inc. announced a voluntary recall of a limited number of 7.2 oz. Snack Factory® Original Pretzel Crisps® and 7.2 oz Snack Factory® Sriracha Lime Pretzel Crisps® packages because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected product.
Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination – Second Expansion
Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail and consumer/user levels. The recall is being initiated due to potential product contamination with the bacteria, Burkholderia cepacia.
FDA Statement on Medical Device User Fee Agreement (MDUFA)
The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.