March 21, 2013 |
The U.S. Food and Drug Administration has announced that New Chapter Inc. is voluntarily recalling a limited number of packages of its 90-count Probiotic Elderberry dietary supplement because it may contain an undisclosed allergen -- soy. "People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product," the FDA said Thursday. " There have been no illnesses reported to date in connection with this product.
CALIFORNIA | LOCAL
September 19, 1997
Re your Sept. 8 editorial on the threats to the Food and Drug Administration: Not only is the legislation and the president's proposal to cut the funding for the FDA a threat to our nation's health, but also the idea of having private firms that manufacture medical devices assess their safety. I live in a retirement community where many people's quality of life depends on the use of wheelchairs, walkers and electrical vehicles. The malfunction or poor quality of these devices can have serious results to those who depend on them.
CALIFORNIA | LOCAL
December 27, 2000
David Willman's report on FDA policies (Dec. 20) correctly analyzes the many difficult issues and conflicting pressures the agency faces in regulating the approval of new drugs. Missing from this analysis, however, is the not inconsiderable pressure the agency has had from Congress to let down the barriers and to speed up the approval process. Following the 1994 conservative revolution, Dick Armey, Tom DeLay, Newt Gingrich and their ilk harassed David Kessler and other FDA administrators to desist from "impeding progress."
October 24, 2013 |
The Food and Drug Administration has laid out a roadmap for greater strictures on the prescribing and dispensing of hydrocodone and analgesics that contain it. The move is the latest in a chain of actions taken by the FDA and other agencies to address a burgeoning U.S. crisis of addiction to opioid painkillers. Under a plan announced by the FDA on Thursday afternoon, products containing the opioid painkiller hydrocodone, including combination analgesics such as Vicodin (which mixes hydrocodone with acetaminophen)
March 21, 2013 |
La Preferida Inc. is voluntarily recalling 56,808 29-ounce cans of La Preferida Whole Pinto Beans, the U.S. Food and Drug Administration announced Thursday. "The manufacturer's preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed," the FDA said. "To date, there have been no reported injuries or adverse events associated with the consumption of this product.
December 3, 2010 |
Invisible braces sound perfect, especially if you're an adult trying to look and act your age. But the FDA says Invisalign, which makes one type of invisible braces, failed to report information on side-effects in patients. Here's the Associated Press story detailing some patients' complaints about allergic reactions to the devices and the FDA advisory letter . And, of course, the response from Invisalign maker Align Technology Inc. in San Jose. None of this is to say that crooked teeth should stay crooked.
June 18, 2013 |
The Food and Drug Administration says it is investigating the unexplained deaths of two patients in the wake of receiving intramuscular injections of the antipsychotic medication Zyprexa (generic name olanzapine). The patients died three to four days after receiving appropriate doses of Zyprexa Relprevv, which is designed to release slowly into the blood over two to four weeks and provide regular dosing for adults with schizophrenia. The FDA says the deaths occurred well after the three-to-four-hour window following injection during which patients should be monitored in a physician's office for a potentially deadly complication called post-injection delirium sedation syndrome (PDSS)
September 11, 2010
While the outrage over salmonella-tainted eggs was rightly focused on Congress' failure to pass long-overdue food safety legislation and the Food and Drug Administration's refusal to require vaccination of chickens, something equally appalling but less noticed had been going on at the two Iowa egg farms involved. Even though U.S. Department of Agriculture employees worked full time at both filthy facilities, there was no word from them about the rodents, maggots and piles of leaking manure.
December 13, 2011 |
U.S. health regulators sent warning letters to eight California surgical centers and a marketing firm for providing misleading information while advertising Allergan Inc.'s Lap-Band, a device used to treat obesity. The U.S. Food and Drug Administration said billboards and advertising inserts used by the surgical centers and the marketing firm 1-800-GET-THIN fail to provide required risk information, including warnings, precautions and possible side effects. The FDA issued warning letters to Bakersfield Surgery Institute Inc, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons, Valencia Ambulatory Center, Cosmopolitan Plastic & Reconstructive Surgery and San Diego Ambulatory Center.
October 30, 2013 |
About 12% of spices imported into the U.S. each year is contaminated with insects, animal excrement, rodent hair and even rubber bands, according to a Food and Drug Administration draft report released Wednesday. The study was conducted in response to recent cases of salmonella found in imported spices. It looked at ways to reduce the rates of human illness caused by contamination in the seasonings. “Nearly all of the insects found in spice samples were stored product pests, indicating inadequate packing or storage conditions.