The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II.
Category Archives: Food Safety News
Whalen’s Horseradish Products, Inc. Issues Allergy Alert on Undeclared Anchovy in Whalen’s Seafood & Burger Sauce
Whalen’s Horseradish Products, Inc. of Galway, NY is recalling WHALEN’S SEAFOOD & BURGER SAUCE, because it contains undeclared anchovy, an element of the Worcestershire Sauce used in the finished product. People who have an allergy to fish run the risk of a serious or life-threatening allergic reaction if they consume this product.
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Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Fresh Cut Fruit Containing Gala Red Apple in a Few States in North East US Because of Possible Health Risk
Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) announced today the voluntary recall of fresh cut fruit containing Gala red apples grown in Pennsylvania. The affected product was distributed to a limited number of customers in a few States in North East US and is being recalled because these apples have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries
OtisMed Corporation (OtisMed) and its former chief executive officer, Charlie Chi, admitted today to intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the U.S. Food and Drug Administration.
FDA resolves criminal and civil actions against Main Street Family Pharmacy
Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
California seafood company to halt production until FDA documents correction of unsanitary practices
On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.