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Recall of Dietary Supplements Found to Contain Sibutramine

  • Published: 2009-04-22 (Revised/Updated 2016-06-13) : Author: Universal ABC Beauty Supply International, Inc.
  • Synopsis: Universal ABC Beauty Supply International, Inc. has been informed by FDA that FDA analyses of dietary supplements distributed were found to contain Sibutramine.

Main Document

"Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion."

Universal ABC Beauty Supply International, Inc. of Brooklyn, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analyses of the dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss.

These dietary supplements are not supposed to contain Sibutramine. The FDA has not approved these products, therefore the safety and effectiveness of these products is unknown.

FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

All lots of the following dietary supplement products are being recalled:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360 C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

NOTE: The above products may have various UPC numbers.

No illnesses or injuries have been reported to the company to date in connection with this product.

Universal ABC Beauty Supply International, Inc. is taking this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers.

Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion. Distributors should contact Sandra Tan by phone at 718-891-6888 or by e-mail at universalabc@aol.com to receive further instructions for returning the product(s). Consumers with questions should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00 pm through 6 pm, EDT.

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3 : FDA Warning: Potential Contamination in Multiple Brands Of Drugs, Dietary Supplements : U.S. Food and Drug Administration.
4 : FDA Warning: Elevated Levels of Belladonna in Certain Homeopathic Teething Products : U.S. Food and Drug Administration.
5 : Laundry Detergent Pods Pose Deadly Risk for Children : Nationwide Children's Hospital.
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