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 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.
Boncheff Greenhouses, Inc. Recalls For Wegmans Food Markets, Inc., Budwey Markets, Wades Market, Cuba Giant Food Market, And Hegedorn’s Cilantro, Curly Parsley, And Italian Parsley Because Of A Possible Health Risk.
Boncheff Greenhouses, Inc. of Toronto, Ontario is issuing a voluntary recall on Cilantro, Curly Parsley, and Italian Parsley, 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.
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Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination
Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus.
Teva Pharmaceuticals, U.S.A issues a voluntary nationwide recall of Metronidazole Tablets USP, 250mg Due to Low Weight Tablets
Teva Pharmaceuticals, U.S.A, is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012. This product lot is being recalled due to the presence of underweight tablets.
SPROUTERS NORTHWEST, INC. RECALLS CLOVER SPROUTS AND CLOVER SPROUT MIXES BECAUSE OF POSSIBLE HEALTH RISK
Sprouters Northwest, Inc. of Kent, WA, is recalling all of its clover and clover mix products 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.
The Ritedose Corporation Announces the Voluntary Nationwide Recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL Due to Mislabeled Unit Dose Vials
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials). This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults.
PRock Marketing, LLC Issues a Voluntary Nationwide Recall of All weight loss formulas and variation of formulas of Reduce Weight Fruta Planta/Reduce Weight Dietary Supplement.
PRock Marketing, LLC located in Central Florida an authorized US distributor of the Authentic Formula Fruta Planta has been informed by the Food and Drug Administration (FDA) that the weight loss dietary supplements sold and marketed contains an undeclared drug ingredient. The FDA lab analysist of the dietary supplements found the Authentic Formula Fruta Planta to contain 15.4 mg of Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
Cumberland Pharmaceuticals Announces Voluntary Recall of Acetadote® Vials
NASHVILLE, Tenn., Dec. 30, 2010 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has implemented a recall of 6 lots of Acetadote® (acetylcysteine) Injection, the Company’s injectable treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland informed the U.S. Food and Drug Administration (FDA) of its plans to voluntarily recall these lots of Acetadote as a precautionary measure based on observed particulate matter found in a very small number of vials.