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Food and Drug Administration 235 articles

Cashews recalled; may contain glass shards

cashews - wikimedia commons

Customer complaints of finding shards of glass in 8-ounce cans of Southern Grove Cashew Halves and Pieces with Sea Salt has prompted the manufacturer to voluntarily recall two lots of the product. The Food and Drug Administration reports that New Jersey-based Star Snacks Co. produced the cashews and distributed them to ALDI stores in Washington DC and 28 states including: Alabama, Arkansas, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Wisconsin and West Virginia. The containers include the UPC code ... Read More

Egg farm cited for salmonella prevention violations

Recall - eggs Mahard Farm, salmonella

A warning letter from the Food and Drug Administration (FDA) to Texas-based Mahard Egg Farm Inc. about serious violations of federal regulations intended to prevent Salmonella contamination in egg production was just made public. The violations were observed at the company’s Sulfur, Oklahoma, facility last October when company representatives were initially warned. The letter acknowledges an email response from the company, but deemed the response insufficient in addressing the agency’s concerns. Food Safety News summed up the violations as “related to fly control, rodents, evidence of wild birds and animals in poultry houses, sheep too near poultry houses and improper ... Read More

First testosterone trial begins

Low T

More than 2,000 plaintiffs from around the U.S. will be watching this week as the first testosterone trial gets underway in Chicago, according to the Cook County Record. It is the first of seven cases in the class action singled out as bellwethers. Thousands of plaintiffs filed suit against multiple drug manufacturers of testosterone replacement drugs saying the drugs increased their risk of life-threatening adverse effects including blood clots, stroke and heart attack. As Beasley Allen previously explained, the U.S. Judicial Panel on Multidistrict Litigation established a multidistrict litigation (MDL) for testosterone replacement drugs in 2014 following a Food and ... Read More

Traditional milk takes aim at plant-based alternatives

milk - Pexels

The milk in your local grocery’s dairy aisle is claiming identity theft, and it even has a proposed bill in Congress to bolster its case. According to Fortune, the milk industry has twice attempted in the last two decades to convince the Food and Drug Administration (FDA) to enforce its definition of milk, “the lacteal secretion…obtained by the complete milking of one or more healthy cows.” The definition means the almond, coconut, soy, cashew or pea milk sold in grocery stores technically doesn’t make the cut. It is a point of contention for traditional milk producers because the FDA has ... Read More

North Carolina woman says prescription drug-induced psychosis led husband to kill daughters

depression

The moment Kim Crespi of Charlotte, N.C., heard that her husband David had stabbed their 5-year-old twin daughters to death, she knew that the real culprit behind the horrific act wasn’t her spouse but a cocktail of prescription drugs, including Selective Serotonin Reuptake Inhibitors, or SSRIs – a form of antidepressants. According to Charlotte’s WBTV, David Crespi, a Charlotte-area banker, called 911 on the morning of Jan. 20, 2006 to report that he had just killed his own daughters. Mr. Crespi was arrested and ultimately took a plea bargain to avoid the death penalty. He is now serving two life ... Read More

FDA sued for failure to publish approval of generic testosterone drug

androgel-pump

Multinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone gel product, even though it had received FDA approval. Ireland-based Perrigo, the largest manufacturer of private label over-the-counter prescription drugs in the United States, said that the FDA failed to update its “Orange Book” listing Approved Drug Products with Therapeutic Equivalence Evaluations. As a result, Perrigo’s testosterone-replacement gel, a generic equivalent of AbbVie’s AndroGel, is not included in the FDA’s therapeutic equivalents (TE) – ... Read More

FDA services scaled back, employees furloughed due to government shutdown

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The government shutdown that began midnight Tuesday will result in the Food and Drug Administration (FDA) temporarily stopping routine facility and food safety inspections. However, the agency will continue to conduct activities vital to public health, including emergencies, high-risk recalls, civil and criminal investigations and import entry reviews. The FDA is a federal agency within the Department of Health and Human Services. The agency is charged with protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines and other biological products, medical devices, most of our nation’s food supply, all cosmetics, dietary ... Read More

New Jersey medical manufacturer ceases production after mold is found in its intravenous drugs

syringe

A U.S. District Judge has shuttered a New Jersey-based manufacturer of medical products for manufacturing and distributing contaminated drugs and other products and for failing to meet the minimum federal standards for safety and current good manufacturing practice requirements, the U.S. Justice Department said in a statement. Med Prep Consulting Inc. of Tinton Falls, N.J., was ordered to halt production after a Connecticut hospital discovered intravenous drugs containing visible contaminants and reported the products to the U.S. Food and Drug Administration (FDA). FDA officials investigated and found the injectable drugs contained mold. Med Prep manufactures a range of drug products ... Read More

Peanut Corporation of America executive indicted by Grand Jury on charges stemming from Salmonella Outbreak

peanut-butter

The owner of Peanut Corporation of America (PCA), where one of the deadliest Salmonella outbreaks in U.S. history originated, has been indicted by a federal Grand Jury on 76 criminal charges. A group of employees and associates of the now-defunct company have also been arraigned in connection to the 2009 outbreak, which killed 9 people and sickened more than 700. According to the indictment, unsealed this week, PCA’s former owner, Stewart Parnell, 58, is charged with committing criminal fraud and conspiracy for allegedly selling and shipping out peanut products known to be contaminated. The Salmonella-tainted peanut butter and other peanut-based ... Read More

New algorithm detects adverse reactions caused by drug combinations

A new algorithm developed by researchers to search through the U.S. Food and Drug Administration’s (FDA) enormous and complex record of drug interaction data reveals what can happen when patients take prescription drugs in combination. The FDA’s Adverse Event Reporting System (AERS) data, an ever-growing database of hundreds of thousands of drug reactions reported directly to the agency from health care professionals and consumers, provides valuable information about prescription drugs and their possible side effects. The new algorithm, however, unlocks more of the database’s potential by finding previously unknown relationships between different drugs and their consequences for patients. Russ Altman, ... Read More