Breaking News
May 24, 2018 - Health Tip: Why Get a Biopsy
May 24, 2018 - Metabolic Syndrome Prevalence by Race/Ethnicity and Sex in the United States, National Health and Nutrition Examination Survey, 1988–2012
May 24, 2018 - Motivation to move may start with being mindful
May 24, 2018 - Advanced genetics study of TB bacteria uncovers virulent ‘Beijing lineage’ strain among young adults
May 24, 2018 - Friends tend to have similar pain tolerance levels, study reveals
May 24, 2018 - Now more of us can count on more time dodging the dementia bullet
May 24, 2018 - Global healthcare access and quality improved from 2000-2016
May 24, 2018 - Virtual follow-up visits for hypertension care just as effective as in-person office visits
May 24, 2018 - New research reveals links between type 1 diabetes and mental health
May 24, 2018 - Antioxidant-enriched multivitamin may decrease respiratory illnesses in CF patients, finds study
May 24, 2018 - Antidepressant treatments increase risk of weight gain, study finds
May 24, 2018 - INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
May 24, 2018 - Poor older adults with Medicaid insurance more likely to die after hospital discharge
May 24, 2018 - Early-life obesity linked to children’s lower perceptual reasoning and working memory scores
May 24, 2018 - Health and diagnostics to soon be digitalized with advent of AI
May 24, 2018 - USC researchers develop new portable device for early-stage malaria detection
May 24, 2018 - Psychologists show that depression accelerates brain aging
May 24, 2018 - Novel IR imaging offers rapid and reliable analysis of cancer tissues
May 24, 2018 - Tau mutations may serve as novel risk factor for cancer
May 24, 2018 - Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
May 24, 2018 - Nurse dead in Congo as Ebola vaccination campaign starts
May 24, 2018 - Unique imaging technique identifies biomarkers of cellular damage done by diabetic retinopathy
May 24, 2018 - Study identifies key food allergy policies that parents want in schools to improve safety of kids
May 24, 2018 - Formaldehyde risk found to be higher in e-cigarettes than originally thought
May 24, 2018 - NIH commences first-in-human trial evaluating experimental treatment for Ebola
May 24, 2018 - Study finds no link between surveillance intensity and detection of recurrence or survival in CRC patients
May 24, 2018 - FDA Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication
May 24, 2018 - Fiber-fermenting bacteria improve health of type 2 diabetes patients
May 24, 2018 - Free e-cigarettes do not help smokers quit, money does finds study
May 24, 2018 - Higher exposure to carbon monoxide in utero increases risk of poor lung function in infants
May 24, 2018 - Neurologists identify new type of vertigo
May 24, 2018 - Scientists identify new inherited neurodevelopmental disease
May 24, 2018 - New family support program improves patient-centered care and lowers hospitalization costs
May 24, 2018 - Researchers take important step toward finding protein biomarkers during cancer surgery
May 24, 2018 - Deadly form of black lung disease found to be increasing among U.S. coal miners
May 24, 2018 - Robust Immune Responses for Herpes Zoster Subunit Vaccine
May 24, 2018 - Optical Coherence Tomography | Texas Heart Institute
May 24, 2018 - Type 2 diabetes slowly rising in Auckland kids – Pacific and Māori have highest rates
May 24, 2018 - Study explores brain chemistry of alcohol exposure in people with family history of AUD
May 24, 2018 - Study shows AVATS procedure as safe, effective alternative for patients deemed ‘inoperable’
May 24, 2018 - Comparative Analysis of a Complex Monoclonal Antibody
May 24, 2018 - Penn investigators discover source of immune molecule involved in nasal polyps, asthma
May 24, 2018 - Berries and Grapes May Keep You Breathin’ Easy
May 24, 2018 - Access and utilization of dental services for Medicaid children 2013-2015
May 23, 2018 - New research raises concern about rate of postpartum hemorrhage
May 23, 2018 - Researchers create new modeling framework that takes a zoonotic perspective on Ebola
May 23, 2018 - Study compares bacteria in humans to the laboratory
May 23, 2018 - Frequent sauna bathing reduces risk of stroke
May 23, 2018 - Landmark trial to test implantable defibrillator in diabetic patients with history of heart attack
May 23, 2018 - Vitamin C consumption may reduce harm to baby’s lungs due to smoking during pregnancy
May 23, 2018 - Researchers complete genomic map of chronic lymphocytic leukemia
May 23, 2018 - Medical students take to the streets to learn about real world problems at the root of poor health
May 23, 2018 - New efforts to curb high blood pressure in Asia
May 23, 2018 - Malaria-causing parasite seeks refuge inside the liver to replicate and survive
May 23, 2018 - Slower rates of stimulation may be more effective in brain therapy, suggests research
May 23, 2018 - Study finds connection between one partner’s BMI and other spouse’s risk of developing diabetes
May 23, 2018 - Mapping the Genes Responsible for Pluripotency
May 23, 2018 - FDA Alert: Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall
May 23, 2018 - Genetic fixer-uppers may predict bladder cancer prognosis
May 23, 2018 - Investigational technology could increase donor organ supply for lung transplants
May 23, 2018 - Prediabetic patients with OSA could lower their resting heart rates by using CPAP
May 23, 2018 - Schizophrenics’ blood samples feature genetic material from more types of microorganisms
May 23, 2018 - Subtle hearing deficits can change the brains of young people
May 23, 2018 - New study shows increased rates of hospitalization for suicide among youths
May 23, 2018 - Proportion of Drug-Intoxicated Organ Donors on the Rise in U.S.
May 23, 2018 - Using virtual biopsies to improve melanoma detection
May 23, 2018 - Compassion meditation training may increase brain’s resilience to suffering of other people
May 23, 2018 - New AAD PSA uses social media imagery to highlight tanning hazards
May 23, 2018 - Frequent MRSA surveillance could contain infection in newborns, study finds
May 23, 2018 - Medicaid expansion linked to reduction in ICU utilization
May 23, 2018 - Proteins moderating nicotine dependence may help fat cells burn energy
May 23, 2018 - Researchers identify mechanisms that regulate mammary gland development
May 23, 2018 - ‘Low-Alcohol’ Booze Labels May Backfire
May 23, 2018 - Social isolation could increase risk of death, hospitalizations for heart failure patients
May 23, 2018 - New research shows that children with autism are able to create imaginary friends
May 23, 2018 - New technology could make prosthetic use more intuitive and reliable
May 23, 2018 - HU researchers explore how simulated microgravity affects gene expression, muscle cell differentiation
May 23, 2018 - Researchers develop injectable bandage to stop fatal blood loss, activate wound healing
May 23, 2018 - Exercising for 4-5 days per week is needed to keep the heart young
May 23, 2018 - Porvair Sciences offers wide range of reagent reservoirs for use with automated liquid handling systems
FDA Alert: Multiple Drug Products by Flawless Beauty: Recall

FDA Alert: Multiple Drug Products by Flawless Beauty: Recall

image_pdfDownload PDFimage_print

January 22, 2018

[Posted 01/22/2018]

AUDIENCE: Consumer, Pharmacy

ISSUE: Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration (“FDA”) to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. View the recall notice for a complete list of affected products. To date, Flawless Beauty has not received any reports of adverse events related to this recall.

BACKGROUND:  All products were sold and distributed over the Internet to U.S. and foreign customers. All glutathione products were sold in multi-vial whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules of vitamin C or sterile water purchased separately or as part of these whitening kits are also recalled:

RECOMMENDATION: Flawless Beauty is notifying its customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty.

Consumers with questions regarding this recall can contact Flawless Beauty by phone at 1-917-831-5948 or jack@flawlessbeautyandskin.com on Monday-Friday, 9:30AM – 5:30 PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
     

[01/19/2018 – Press Release – Flawless Beauty]

Tagged with:

About author

Related Articles