FDA warning
This article was originally published in The Rose Sheet
Executive Summary
Tedco Inc.'s Miracle II Neutralizer products "are bacterially contaminated and have not been proven to be safe and effective," agency says in Dec. 6 press release. "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," FDA cautions, adding company has refused a voluntary recall. Tedco markets Miracle II Gel for unapproved uses such as diaper rash, diabetes, gout, psoriasis and skin cancer, according to the agency. Additional claims include "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," FDA says. "Contrary to such claims, recent FDA testing of Miracle II Neutralizer and Miracle II Neutralizer Gel revealed bacterial contamination and poor manufacturing conditions," agency states...
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.