The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.
Category Archives: Food & Drug Recalls
Chetak New York L.L.C. Recalls 14.1 oz. Jar of "Deep Coriander Powder" Because of Possible Health Risk
Chetak New York L.L.C. of Edison, NJ is recalling 300 jars of 14.1oz “Deep Coriander Powder”, Lot# LE15152, because they have the potential to be contaminated with Salmonella, 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.
FDA approves first treatment for sexual desire disorder
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns
Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns.
Federal judge approves consent decree with Iowa drug and dietary supplement maker, Iowa Select Herbs
Today, U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.
Good Seed Inc. Recalls Soybean Sprouts & Mung Bean Sprouts Due To A Possible Health Risk
Good Seed Inc. of Springfield, VA is voluntarily recalling all packages of soybean sprouts and mung bean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.
NORTHWEST FARM FOOD COOPERATIVE VOLUNTARILY RECALLS FROZEN RAW CAT FOOD DUE TO POSSIBLE SALMONELLA CONTAMINATION
Northwest Farm Food Cooperative of Burlington, WA, is voluntarily recalling frozen raw Cat Food with the code Jul12015B due to their potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products.
Kent, Washington Firm Issues Allergy Alert On Undeclared Peanut Ingredients
Real Foods of Seattle, LLC of Kent, WA is recalling 29 cases of Harvest Slaw Kit and 13 cases of Broccoli Salad Kit because it may contain undeclared peanut ingredients. No other products are impacted by this recall. This recall is being conducted in coordination with the U.S. Food and Drug Administration (FDA). People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Blue Square Market Issues Voluntary Nationwide Recall of Kaboom Action Strips and Lida Daidaihua Due to the Presence Of Undeclared Sulfoaildenafil, Sibutramine And Phenolphthalein
Blue Square Market Inc. of North Huntingdon, PA, is recalling “Kaboom Actions Strip 12 Pack” and LiDa DaiDaiHua to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients. Kaboom was found to contain sulfoaildenafil and LiDa DaiDaiHua was found to contain sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of heart attacks and strokes. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.
Mahina Mele Farm Recalls Their Macadamia Nut Products Due to Possible Health Risk
Mahina Mele Farms is recalling the following products after FDA testing found Salmonella in macadamia nuts. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.