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Recall -- Firm Press Release

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Flawless Beauty and Skin Issues Voluntary USA Recall of Unapproved Drugs


Contact:
Consumer:
1-917-831-5948
sweetsuzzy@flawlessbeautyandskin.com

Media:
Jack Gindi
1-917-653-3856

FOR IMMEDIATE RELEASE —April 29, 2014 – Asbury Park, NJ, 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. To date, Flawless Beauty and Skin has not received any reports of adverse events related to this recall.

The following products were distributed in the US to wholesale, retail & Internet customers:

NAME

STRENGTH

UPC

LOT/BATCH #

EXP.DATE

Roche Laroscrobine Platinum

1gm Vitamin C + 0.35gm Collagen

*3421357*

F040

08-2016

Tatiomax Reduced Glutathione + Hydrolyzed Collagen

1200mg Reduced Glutathione + 200mg Reduced Collagen

4973430081576

UB302

5-12-15

Saluta Glutathione Rx

600mg Glutathione

6920425209014

201302275

201308384

1/20/15

10/19/2015

Relumins Advanced Glutathione

1500mg Glutathione + 500mg Vitamin C

700175760302

130616

2016.06

TP Drug Laboratories Vitamin C

500mg

8853533000533

556273

556219

25/9/16

2/8/16

Rx Sterile Water for Injection

N/A

4800573016219

16U421

16U423

16U394

08-2016

09-2016

04-2016

TP Drug Laboratories Vitamin C

N/A

N/A

Reg.No.:

1A1557/30

N/A

 

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.

Consumers with questions regarding this recall can contact Flawless Beauty and Skin by +1-917-831-5948 or sweetsuzzy@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 this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Page Last Updated: 04/29/2014
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