The FDA today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.
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FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product.
FDA launches public education campaign to encourage adult smokers trying to quit cigarettes
Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations and convenience stores – retail locations where smokers face a multitude of triggers and that typically feature cigarette advertisements. The “Every Try Counts” campaign targets smokers ages 25-54 who have attempted to quit smoking in the last year but were unsuccessful. The two-year campaign launches next month in 35 U.S. markets and features print, digital, radio, and out-of-home ads, such as on billboards.
Harvesters Issues Safety Alert on Bibi Frutix Candy Possible Chemical Contamination
On Tuesday, December 5, a partner food pantry agency in Wamego, Kansas notified Harvesters—The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters’ distribution program. The candy product is likely contaminated with a chemical substance and is potentially harmful if eaten.
ALDI Voluntarily Recalls Choceur Dark Chocolate Bar Due to Undeclared Nut Allergen Products Could Contain Almond Pieces Not Listed on Packaging
In cooperation with Hofer KG ZNL Schokoladefab, ALDI has voluntarily recalled Choceur Dark Chocolate Bars as a precautionary measure due to the potential presence of almond pieces not listed on packaging. The recall was initiated after an ALDI employee identified almond pieces in the product. This product may cause an allergic reaction in customers who have a nut allergy.
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Creative Contract Packaging LLC Issues An Allergen Alert Regarding 4 Ounce Jars Of Herb-Ox® Beef Flavor Granulated Bouillon Due To Potential Presence Of Undeclared Milk
Creative Contract Packaging LLC is voluntarily recalling 4,412 cases, or 13,236 total pounds, of two code dates of HERB-OX® Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.
Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues
Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.
FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride
The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.