Tag: FDA Warning

FDA Warns Of Undeclared Ingredient In 'Big Penis' Supplement

The U.S. FDA is warning of a male sexual stimulant that was discovered to contain undeclared Viagra. It could pose health risks for those who are taking other prescription drugs.

Public Health July 18, 2019

FDA Strengthens Warning Regarding Link Between Breast Implants And Cancer But Continues To Allow Implant Sales

Despite acknowledging that breast implants can increase cancer and autoimmune disease risks, the Food and Drug Administration isn’t planning to ban their sales yet. Instead, it issues guidelines to improve patient and healthcare provider information.

Public Health May 4, 2019

FDA Finds Listeria In 19 Ice Cream Manufacturing Plants

Federal inspectors have detected listeria contamination in 19 different ice cream manufacturing facilities. The discovery has led to several product recalls and the closure of one ice cream maker.

Public Health April 26, 2019

FDA Warns Of Pre-owned, Unauthorized Medical Test Strips Sold Through Amazon, eBay, And Craigslist

Consumers should avoid buying and using pre-owned or unauthorized home use test strips through online marketplaces, according to the FDA. Many of these products might prove to be unsafe to use by patients.

Public Health April 20, 2019

FDA Warns Against Consuming Food Products Made Using Liquid Nitrogen

Food products prepared with liquid nitrogen pose serious injury risk if the liquid nitrogen is infused to the product immediately before consumption or sale. It may cause skin damage, internal organ injury, and even breathing difficulties.

Public Health September 1, 2018

FDA Warns About Dog Food That May Bring Heart Disease

The FDA warned pet owners about certain types of dog food that could make dogs at risk of a heart disease. The cases were particularly worrisome because they involved dog breeds that are not genetically prone to develop the disease.

Healthy Living/Wellness July 15, 2018

FDA Warns Of EpiPen Shortage: How To Be Prepared When You Need An Emergency Allergy Shot

EpiPens and generic versions are facing a shortage in the United States, says the FDA. Here's how to deal with this issue and survive the shortage.

Public Health May 10, 2018

Bayer Essure System For Permanent Birth Control Receives Label Update

Once again, the American Food and Drug Administration slapped restrictions on Bayer for its controversial Essure implant. The device now comes with a checklist that must be signed by the patient before insertion.

Public Health April 10, 2018

FDA Issues Safety Warning Against Anesthetic Use In Pregnant Women, Children Below 3

FDA warning raised concern about prolonged or repeated use of anesthetics in infants or mothers in their third trimester of pregnancy. The practice was associated with cognitive development issues as well as behavioral consequences.

Public Health December 15, 2016

Prescription Testosterone, Other Steroid Drugs Product Labels Get New Warning From FDA

The U.S. Food and Drug administration is stepping up with warnings for prescription drugs that treat low testosterone. The abuse of the said drugs has been proven to be linked with heart-related and mental health problems, among others.

Medicine October 26, 2016

Voluntary Recall Issued For Entenmann’s Little Bites Products

The 5- and 10-pack variants of Little Bites chocolate chip muffins are included in the voluntary recall issued by Entenmann’s-owner Bimbo Bakeries. According to the recall notice, affected products present choking and/or cutting hazard.

Public Health September 1, 2016

Not-So-Wholesome Products From Whole Foods? FDA Slams Whole Foods For 'Serious Violations'

The FDA has warned Whole Foods regarding several instances of food safety violations that inspectors found in the company's Massachusetts facility. Violations include failing to sanitize food preparation surfaces and placing food near dirty dishes.

Public Health June 16, 2016

Infection Risks Prompt FDA To Recall Endoscope Washers

In the latest of FDA safety warnings, the agency said Custom Ultrasonics failed to validate that its AERs can sufficiently wash and disinfect endoscopes. The AERs were implicated in recent CRE outbreaks in hospitals.

Life November 14, 2015

FDA Sends Warning To Three Companies Over Direct-To-Consumer Gene Tests

FDA warning letters were sent to diagnostic companies DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc. The notifications had to do with direct-to-consumer genetic tests believed to be marketed to the public without FDA clearance.

Life November 11, 2015

FDA Warns Heart Device Maker St. Jude About Nonconforming Manufacturing Practices At Atlanta Plant

The FDA cited certain 'nonconformities' in St. Jude Medical's manufacturing practices at the Atlanta plant where it creates the heart failure monitor CardioMEMS HF system. The company previously faced a similar FDA warning in its plant in Sylmar, Calif.

Life October 5, 2015

FDA Orders Halt Of Sales Of Four New Cigarette Brands Out Of Health Concerns

The FDA orders R.J. Reynolds to stop sales of four brands, calling them 'mislabeled and adulterated.' Retailers will be given 30 days to remove them from store shelves, the FDA says.

Life September 16, 2015

Companies Selling Powdered Caffeine Get New Warnings From The FDA

FDA sends warning letters to five distributors of powdered caffeine. Companies are selling in bulk without providing any guidance on safe amounts that can be consumed, FDA says.

Life September 3, 2015

FDA Tells KIND Snacks To Stop Adding 'Healthy' Label To Packaging

KIND bars aren’t healthy — at least according to the standards set by the FDA, which means the brand will no longer be allowed use the term in labeling.

Life April 16, 2015

40 Patients Accidentally Given Non-Sterile IV Fluid: One Death Confirmed

Intravenous saline solutions intended for training purposes were accidentally administered to patients, resulting in at least one death. The FDA is investigating the incident, advising medical staff to be more thorough in the meantime.

Life January 15, 2015

FDA Warns This Gynecological Device Could Spread Cancer

Laparoscopic power morcellators could spread cancer in women being treated for uterine fibroids, an updated warning from the Food and Drug Administration warns.

Life November 24, 2014

Real Time Analytics