Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
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Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
Dedinas Franzak Enterprises Issues Allergy Alert On Undeclared Milk In "Butter Flavored Popcorn"
Dedinas Franzak Enterprises of Grand Rapids, MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Rajbhog Distributors GA Inc. Issues Allergy Alert on Undeclared Almonds in JALEBI
Rajbhog Distributors GA. Inc. of Tucker GA-30084 is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs. People who have an allergy or severe sensitivity to Almonds run the risk of serious or life- threatening allergic reaction if they consume these products.
FDA approval brings first gene therapy to the United States
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
FDA approves new antibacterial drug
The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.
FDA approves first U.S. treatment for Chagas disease
The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.
Dedinas-Franzak Enterprises Issues Allergy Alert On Undeclared Milk In Big Win Butter Popcorn
Dedinas-Franzak Enterprises is recalling Big Win, Butter Popcorn Artificially Flavored 5 OZ, UPC #0-11822-58492-0, This product is artificially flavored and milk is not specifically called out in the Allergen Statement. The product may contain milk and people who have an allergy or severe sensitivity to Milk may run the risk of serious or life-threatening allergic reaction if they consume this product. The concern was identified through a non-illness consumer complaint in relation to flavor.
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.
FDA warns US Stem Cell Clinic of significant deviations
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific
Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice
requirements, including some that could impact the sterility of their products, putting patients at risk.