The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion.
Category Archives: Food & Drug Recalls
Reser’s Fine Foods, Inc. Recalls Refrigerated Ready-to-Eat Products Due to Potential Health Risk
Reser’s Fine Foods of Beaverton, Oregon is recalling approximately 109,000 cases of refrigerated ready-to-eat products because it may be contaminated with Listeria monocytogenes. Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems.
Sunny Pine Farms Recalls Chevre Cheese Because of Possible Health Risk
Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Chevre, Organic Parsley Chive Chevre and Organic Honey Lavender Chevre due to possible improper pasteurization. Pasteurization heats milk to effectively eliminate all illness-causing bacteria such as Listeria monocytogenes and Salmonella.
Price Chopper Supermarkets Recalls Coconut Custard Pies
Price Chopper Supermarkets is issuing a recall on Price Chopper eight inch (8”) and ten inch (10”) coconut custard pies, with UPC numbers 41735 23713, 41735 23721 and 41735 22453 due to a lack of ingredient information on the label; the pies contain milk, egg, soy, wheat and tree nut (coconut), which are known allergens. Other than this labeling issue, the product is safe for consumption for those not allergic to the above allergens.
FDA takes enforcement action against Oregon dietary supplement manufacturer
The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
FDA awards 15 grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.
Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products
Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.
FDA approves Opsumit to treat pulmonary arterial hypertension
The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCL Injection, USP), 75mg/30ml, Single-Dose – Preservative Free Vial Due to Presence of Particulate Matter
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine™ (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass.
Fahman Enterprises Inc. – Recalls Pran Brand Turmeric Powder Due to Elevated Levels of Lead
FAHMAN ENTERPRISES INC. of Dallas, TX is voluntarily recalling PRAN TURMERIC POWDER because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women if consumed. The recall was initiated after it was discovered that product contained high levels of lead (48 ppm) based on sampling by The Food and Drug Administration.