In a letter sent today to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.
Category Archives: Drug Recalls & Safety Notices
FDA says Tessalon liquid cough capsules pose risk for young children
The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.
U.S. Marshals seize FDA-regulated food stored at rodent-infested warehouse in New Mexico
U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized chili pods, ground chili, crushed chili, and other chili products located in the rodent-infested food warehouse owned by Duran and Sons LLC in Derry, New Mexico. The New Mexico Environment Department had previously placed an embargo on all products in the company’s food warehouse on Nov. 17, 2010.
FDA warns consumers to avoid Man Up Now capsules
The U.S. Food and Drug Administration is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.
FDA issues guidance on public comment procedures at advisory committee meetings
The U.S. Food and Drug Administration today issued final guidance for people who wish to comment during the agency’s advisory committee meetings. The guidance provides instructions on how to request a time to speak and how FDA staff should respond to requests to speak at the meetings. (PCE)
FDA Permits Wright County Egg to begin shipping shell eggs to consumers
November 30 2010 — FDA today notified Wright County Egg LLC of Galt, Iowa, that the company has FDA’s concurrence to begin shipping shell eggs directly to the consumer market from two hen houses on one of its six farms. The firm has not shipped eggs to the consumer market since August 2010, when the company’s eggs were associated with the multi-state outbreak of Salmonella Enteritidis (SE). (DSK)
FDA warns consumers not to use Vigor-25
Marketed as a ’male sexual stimulant,’ product contains hidden drug ingredient
The U.S. Food and Drug Administration says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.
Xanodyne agrees to withdraw propoxyphene from the U.S. market
Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the painkiller propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food Administration. The FDA has also informed generic manufacturers of Xanodyne’s decision and they will be removing their propoxyphene-containing products from the market as well.
FDA approves Xgeva to help prevent cancer-related bone injury
Xgeva, cancer
FDA Warning Letters issued to four makers of caffeinated alcoholic beverages
The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law. (DSK)