[Posted 03/21/2017] AUDIENCE: Plastic Surgery, Oncology, Patient ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data…
Would Your Child Benefit from a Clinical Trial?
Get Consumer Updates by email. You may have heard of clinical trials, and your doctor may even have suggested your child enroll in one. Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new…
EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms® Pig Ears Because of Possible Salmonella Health Risk
EuroCan Manufacturing is voluntarily recalling Lot Number 84 consisting of it’s individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms®, HoundsTooth® and Mac’s Choice® Pig Ears because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to humans from handling contaminated pet…
Nutiva Voluntary Recall for Undeclared Peanuts Organic Plant Based Protein Superfood 30 Shake Vanilla Flavor
Nutiva, an Organic Superfoods company, has initiated a voluntary product recall of the following Organic Plant Based Protein Superfood 30 Shake – Vanilla Flavor products after identifying that this product may contain peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume…
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers – FDA Investigating Increased Rate of Major Adverse Cardiac Events
[Posted 03/18/2017] AUDIENCE: Cardiology, Surgery, Risk Manager ISSUE: The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic…
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone. Recalled Product Details: Wellness 95% Beef Topper for Dogs – 13.2 oz Best-By Dates of 02 FEB 19, 29 AUG 19 and 30 AUG 19, located on the bottom…
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult DogsDue to Potential Health Risk
Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones. Dogs ingesting high levels of beef thyroid hormones may exhibit symptoms such as increased thirst and…
Aroma Imports Inc. Recalls Nabelsi brand Thyme Because of Possible Health Risk
Aroma Imports Inc. of Dearborn Heights, MI, is recalling 450 g and 4.5 kg packages of Nabelsi brand Thyme because the products have the potential to contain excessive levels of lead. The recall was initiated after it was discovered that product contained high levels of lead (422 PPM) based on sampling by U.S. Food and…
Advanced Fresh Concepts Franchise Corp. Voluntarily Recalls Edamame Due to Potential Health Risk
Advanced Fresh Concepts Franchise Corp. (“AFC”) of Rancho Dominguez, California is recalling its Edamame (Soybeans) – UPC 0-23012-00261-9, dated between 01/03/2017 and 03/17/2017 because it has the potential to be contaminated with Listeria monocytogenes. Contamination was discovered via random testing under AFC’s Quality Assurance Program. Listeria monocytogenes is an organism which can cause serious and…
March 14, 2017: Woman Admits to Causing the Death of Another Person by Injecting Her with Liquid Silicone
Food and Drug Administration Office of Criminal Investigations ATLANTA – Deanna Roberts has pleaded guilty to four felony counts of possessing, transporting, and ultimately illegally injecting persons with liquid silicone and four felony counts of introducing into interstate commerce liquid silicone, which was an adulterated device. One…