Product Liability

FDA recalls dietary supplements for undeclared substance

The Food and Drug Administration (FDA) his issued a recall to consumers and pharmacists for 34 dietary supplements manufactured by ABC Beauty Supply following an FDA lab analysis that identified an undeclared substance that may present a significant risk for patients with a history of heart conditions or stroke.

The undeclared substance, Sibutramine, is an FDA-approved drug used as an appetite suppressant for weight loss. However, the recalled ABC Beauty Supply products are not supposed to contain Sibutrame and thus, with their current formulations, are not approved by the FDA and are of unknown safety and effectiveness. The products pose a threat because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk with patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

The recalled products are
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 360ยบ 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

No illnesses or injuries have been reported to the company to date in connection with any of the recalled products.

Consumers are advised not to consume any of the recalled products and should return any dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion. Consumers with questions should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00 pm through 6 pm, EDT.

Source:
FDA