The Food and Drug Administration (FDA) is advising consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc., of West Monroe, La. because the products are bacterially contaminated and have not been proven to be safe and effective. Use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems who are particularly susceptible to illness.
"We will not tolerate the marketing of products that use deceptive and untruthful claims to lure consumers into potentially dangerous situations," said Margaret O'K. Glavin, FDA's associate commissioner for regulatory affairs. "We consider it a significant public health hazard when consumers are deliberately deceived into using potentially dangerous products that promise health benefits but deliver only risk of harm."
Tedco, Inc., promotes Miracle II Neutralizer for ophthalmic use, including treatment of cataracts and pink eye, and as an eyewash. FDA requires that all ophthalmic products be sterile. Due to the substantial risk posed by non-sterility, Miracle II Neutralizer should never be applied to the eyes.
Tedco, Inc., also markets Miracle II Neutralizer for other unapproved uses, including treatment of AIDS, cancer, Crohn's Disease, dermatitis, diaper rash, diabetes, ear ache, hemorrhoids, hives, gout, herpes, mouth ulcers, psoriasis, skin cancer, and yeast infection. The firm sells Miracle II Neutralizer Gel for many of the same unapproved uses, including diaper rash, diabetes, gout, psoriasis, and skin cancer.
Tedco, Inc., promotes its Miracle II products with claims such as, "Supreme technology has made possible for a perfect soap cleaner, deodorizer, natural insecticide and antibacterial product to be put on the market. This is the only product that is made in the world that can wash a newborn baby or clean up an oil spill and everything in between." Contrary to such claims, recent FDA testing of Miracle II Neutralizer and Miracle II Neutralizer Gel revealed bacterial contamination and poor manufacturing conditions.
Although Tedco, Inc. has been advised by FDA of the contamination found in its Miracle II Neutralizer and Miracle II Neutralizer Gel products, the firm has declined to voluntarily remove the products from the market.
A number of stores sell Miracle II Neutralizer and Miracle II Neutralizer Gel, and the products are distributed and sold worldwide and sold via the Internet.
The FDA urges consumers, healthcare providers, and caregivers to cease using and dispose of these products and report any adverse events related to these products to MedWatch, the FDA's voluntary reporting program at 1-800-FDA-1088.
Source: FDA
Product Locator: Spring and Early Mother's Day Gift Guide for Infection Prevention Personnel
March 27th 2024Whether it's a spring holiday, birthdays, or no reason at all, infection prevention personnel love to give and receive gifts that help at the end of a stressful day. Infection Control Today® offers some gift ideas for infection prevention personnel and their families.
Catching Up With Vangie Dennis, AORN 2022-2023 President at AORN 2024
March 26th 2024Infection Control Today (ICT) had the privilege of catching up with Vangie Dennis, MSN, RN, CNOR, CMLSO, at the Association of periOperative Registered Nurses' (AORN’s) International Surgical Conference & Expo 2024. As the former president of AORN and an esteemed figure in perioperative services, Vangie Dennis shared insights into her recent endeavors and the exciting new chapter she's embarked upon.
How To Optimize Your Time Management Strategies for the Busy Infection Preventionist
March 25th 2024Is your calendar resembling a chaotic masterpiece of overlapping tasks? Join the club of infection preventionists striving to balance responsibilities. Dive into proven strategies from a fellow infection preventionist to reclaim control of your time, streamline tasks, and boost productivity effectively. This is an IP Lifeline article.
CenTrak Unveils Revolutionary BLE Multi-Mode Platform for Health Care RTLS Solutions
March 22nd 2024CenTrak, the industry leader in real-time location technology, introduces the groundbreaking BLE Multi-Mode Platform, setting a new standard for Real-Time Location Systems (RTLS) in health care. Discover how this innovative solution enhances location data precision and streamlines operations for health care organizations.