FDA allows marketing of four “next generation” gene sequencing devices

Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).

Blount Fine Foods Voluntary Recall of “Wegmans New England Clam Chowder” Due to Possible Undeclared Crab Allergen

Blount Fine Foods of Fall River, MA is recalling a single lot code of Wegman’s branded refrigerated New England Clam Chowder in 16 ounce retail cup pack size because of undeclared crab allergen. People who have an allergy or severe sensitivity to crab run the risk of suffering serious or life-threatening reactions if they consume this product.

Jobbers Wholesale Issues Voluntary Recall of Rhino 5 Plus, Maxtremezen and Extenzone Marketed as a Dietary Supplement Due to the Presence of Undeclared Drug Ingredients

Paramount, CA, Jobbers Wholesale is voluntarily recalling Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone to the consumer level. FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine.

U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized products is more than $2 million.

FDA Classifies Medtronic’s Worldwide Voluntary Field Action on Guidewires as Class I Recall

Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to certain guidewires as a Class I recall.
Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.