Agency strategy caps maximum at 325 milligrams to reduce risk of liver toxicity.
Category Archives: Drug Recalls & Safety Notices
FDA inspects retailers in Miss.; issues warning letters for illegal tobacco sales to minors
The U.S. Food and Drug Administration today announced it is issuing its first warning letters to retailers for the illegal sale of tobacco products to minors in violation of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Using state inspectors who have been commissioned by the agency, the FDA visited 493 different retail establishments in Mississippi over the past three months and issued 25 warnings.
FDA warns public of continued extortion scam by FDA impersonators
The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued international extortion scam.
FDA approves opioid analgesic to help cancer patients manage pain
Enrollment in REMS program required for health care professionals
FDA launches website to help regulated industries save time, resources
The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.
FDA to require substantial equivalence reviews for new tobacco products
The U.S. Food and Drug Administration announced today that any tobacco product introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.
FDA warns consumers not to use Fruta Planta weight loss products
• PRock Marketing LLC, of Kissimmee, Fla., is recalling all lots of Fruta Planta and Reduce Weight Fruta Planta. This is a single product marketed under two brand names.
FDA: Gardasil approved to prevent anal cancer
The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.
FDA announces recall of Abbott glucose test strips
glucose test strips, Abbott
FDA begins process to remove breast cancer indication from Avastin label
The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.