Recall of Dietary Supplement Products having Undeclared Drug Ingredient
Posted by
Jessica SmagaczApril 22, 2009 1:58 PMFDA recently reported on a recall from Universal ABC Beauty Supply International, Inc. of Brooklyn, NY. FDA informed the company that lab analyses of the dietary supplements distributed by the company contained undeclared Sibutramine. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. However, those dietary supplements are not suppose to contain Sibutramine.
FDA has not approved the dietary supplements and therefore the safety and effectiveness of these products is unknown.
FDA says that these particular products pose a threat to consumers. “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.”
Here is the list of dietary supplement products being recalled as posted on the FDA website:
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 360º 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
“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.”