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Flawless Beauty and Skin Products: Recall - Unapproved Drugs
Includes the following products:
- Roche Laroscrobine Platinum
- Relumins Advanced Glutathione
- QAF Pharmaceuticals Inc. Philippines Saluta Glutathione Rx
- Tatiomax Reduced Glutathione + Hydrolyzed Collagen
- TP Drug Laboratories Vitamin C
- Rx Sterile Water for Injection
AUDIENCE: Consumer, Health Professional
ISSUE: Flawless Beauty and Skin is voluntarily recalling eleven (11) lots of Roche Laroscrobine Platinum, Relumins Advanced Glutathione, QAF Pharmaceuticals Inc. Philippines Saluta Glutathione Rx, Tatiomax Reduced Glutathione + Hydrolyzed Collagen, TP Drug Laboratories Vitamin C, and Rx Sterile Water for Injection to the retail and consumer level. These products are currently unapproved drugs in the US.
These products claim to treat scurvy, degenerative brain and liver diseases, alcoholic liver disease, and serve as antidotes to various drugs. The label claims may result in patients not seeking proper medical treatment. Furthermore, the fact that these products may be administered intramuscularly or intravenously heightens the risk associated with unknown quality, safety, or efficacy.
BACKGROUND: The affected products were distributed in the US to wholesale, retail & Internet customers. See the firm Press Release for a listing of specific UPC, lot numbers, and expiration dates.
RECOMMENDATION: Flawless Beauty and Skin is notifying its distributors and 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 and Skin.
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.htm
- 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
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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