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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Flawless Beauty LLC: Various Injection Kits and Supplements Recalled for Unapproved Drug Claims

Agency Publication Date: February 5, 2018
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Summary

Flawless Beauty LLC is recalling all lots of various injectable whitening kits, vitamin supplements, and medical solutions including Relumins, Tatiomax, and Saluta products. These products were marketed as unapproved new drugs and were misbranded, meaning they have not been evaluated by the FDA for safety or effectiveness for their intended uses. Consumers should immediately stop using these products and contact a healthcare professional, as unapproved injectable drugs can pose significant health risks if they are contaminated or administered incorrectly.

Risk

These products are unapproved new drugs that have not undergone FDA safety or efficacy reviews, and their manufacture may not meet standards required for injectable products. Using unapproved injectable substances can lead to serious infections, adverse reactions, or toxic effects since the purity, strength, and sterility of the products cannot be guaranteed.

What You Should Do

  1. Check your supplies for any of the affected products, including Relumins Glutathione kits (900mg, 1500mg, 3000mg), Tatiomax Whitening kits, Saluta Glutathione, Laroscorbine Platinum, Tationil, Laennec INJ, Reiki kits, Ling Zhi capsules, or TP Drug Laboratories Vitamin C ampules.
  2. Identify the affected products by checking for any lot numbers, as this recall includes all lots of the listed products sold individually or as part of multi-unit kits.
  3. Immediately stop using all recalled products and do not administer any remaining injections.
  4. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or to discuss safe alternatives to these unapproved treatments.
  5. Return any unused products to the place of purchase for a refund and contact Flawless Beauty LLC for further instructions regarding the return process.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Relumins Advanced Glutathione kits (900 mg vials, 1500 mg vials, 3000 mg vials)
Model:
D-0324-2018
Lot Numbers:
all lots
Product: Relumins Vitamin C Solvent ampules
Model:
D-0325-2018
Lot Numbers:
all lots
Product: Tatiomax Gluatathione Whitening kits (1400mg vials)
Model:
D-0326-2018
Lot Numbers:
all lots
Product: Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm
Model:
D-0327-2018
Lot Numbers:
all lots
Product: Tationil Glutathione (600 mg/ 4 mL)
Model:
D-0328-2018
Lot Numbers:
all lots
Product: Laennec INJ, Placenta extract (human) (2mL vials)
Model:
D-0329-2018
Lot Numbers:
all lots
Product: Reiki Glutathione Whitening kits
Model:
D-0330-2018
Lot Numbers:
all lots
Product: TP Drug Laboratories Vitamin C ampules
Model:
D-0331-2018
Lot Numbers:
all lots
Product: Sterilized water for injections BP (50 x 5 mL plastic ampules)
Model:
D-0332-2018
Lot Numbers:
all lots
Product: Ling Zhi capsules
Model:
D-0333-2018
Lot Numbers:
all lots
Product: Saluta Glutathione Whitening kits (600 mg, 1200 mg, 1800 mg glass vials)
Model:
D-0334-2018
Lot Numbers:
all lots
Product: TAD Glutathione Whitening Kits lyophilized powder (600 mg vials)
Model:
D-0335-2018
Lot Numbers:
all lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78991
Status: Resolved
Manufacturer: Flawless Beauty LLC
Sold By: Flawless Beauty LLC; Flawless Beauty and Skin
Manufactured In: United States, Japan, Korea, India, China, Italy
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.