PDA

View Full Version : All lots 34 dietary supplement products distributed by Universal ABC Beauty Supply


notyard
04-22-2009, 07:58 PM
FDA recall press release:

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Universal ABC Beauty Supply International, Inc. Issues a Voluntary Nationwide Recall of Dietary Supplement Products Found to Contain an Undeclared Drug Ingredient

Contact:
Sandra Tan
(718) 891-6888

FOR IMMEDIATE RELEASE -- April 20, 2009 -- 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 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</STRONG>
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 (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.

notyard
08-01-2009, 11:47 AM
FDA class I recall still in progress:

PRODUCT
1) ProSlim Plus -- 100% Natural -- Supplement for Diet Support -- 60 Capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 928761 589144. Recall # D-1767-2009;
2) 3 Days fit -- 60 capsules (400 mg) per bottle, packaged in a box -- UPC 4 965831 587563. Recall # D-1768-2009;
3) Eight Factor Diet -- 60 capsules, 3 pouches per box -- Made in Japan -- UPC 4 961985 823656. Recall # D-1769-2009;
4) 24hours Diet -- 24 hours, Chain Fat Burning Reaction with Double Effects -- 60 Capsules per bottle, packaged in a box -- UPC 4 958564 525322 -- Made in Japan. Recall # D-1770-2009;
5) Slim 3in1 M-18 Royal Diet -- 90 capsules, 3 pouches per box -- UPC 4 897005 120125. Recall # D-1771-2009;
6) 3X Slimming Power -- 60 capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 967845 695555. Recall # D-1772-2009;
7) Extrim Plus 24 Hours Re-Burn Formula -- 60 capsules per bottle, packaged in a box -- UPC 4 956825 856253 -- (LOS-DO sample 499881 and found at firm). Recall # D-1773-2009;
8) Slim 3in1 Extra Slim Formula -- 90 capsules, 3 pouches per box – Made in Japan -- UPC 4 926385 914229. Recall # D-1774-2009;
9) Slim 3in1 Extra Slim Waist Formula -- 100% All Natural -- 90 Capsules, 3 pouches per box -- Made in Japan -- UPC 4 960052 408604. Recall # D-1775-2009;
10) Slim Express 360 C -- 90 capsules per box -- UPC 4 963652 152359; and 60 capsules per box containing 3 foil-like pouches, 20 capsules per pouch – Made in Japan. Recall # D-1776-2009;
11) Slim Express 4in1 -- 60 Capsules per bottle, packaged in a box -- Made in Japan - UPC 4 963562 412260. Recall # D-1777-2009;
12) Royal Slimming Formula -- 60 capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 958587 987770. Recall # D-1778-2009;
13) Body Creator -- 100% NATURAL -- 90 capsules, 3 pouches per box – Made in France -- UPC 3 027945 861623. Recall # D-1779-2009;
14) Slim Waistline (labeling written in Chinese) --packaged in a box -- UPC 4 925105 880219. Recall # D-1780-2009;
15) Body Shaping -- 100% Natural -- 90 capsules per box containing 3 pouches, 30 capsules per pouch – Made in France -- UPC 3 062569 747809. Recall # D-1781-2009;
16) Perfect Slim -- 100% All Natural -- 90 Capsules, 3 pouches per box. Recall # Recall # D-1782-2009;
17) Perfect Slim -- No 1. 4 -- 5X -- Super Slim Power -- 100% Natural -- 60 capsules per bottle, packaged in a box -- Made in Japan. Recall # D-1783-2009;
18) Imelda Perfect Slim -- 60 capsules per bottle, packaged in a box -- Made in Hong Kong. Recall # D-1784-2009;
19) Slim Waist Formula -- 32 capsules, 2 pouches per box. Recall # D-1785-2009;
20) Super Slimming -- 60 capsules per bottle, packaged in a box -- Made in Japan. D-1786-2009;
21) 2 Day Diet -- Japan Lingzhi -- Slimming Formula -- Fat Burner -- 60 capsules per bottle, packaged in a box – Made in Japan. Recall # D-1787-2009;
22)Powerful Slim - The slimming total effect -- No. 1 Slim. Product of Japan -- packaged in a box containing two pouches, 16 capsules per pouch. Recall # D-1788-2009;
23) Body Shaping -- 90 capsules per box, each box contains 3 pouches of 30 capsules each. Product of France. Recall # D-1789-2009;
24) Super Fat Burner -- 60 Capsules per bottle, packaged in box -- Made in Japan. Recall # D-1790-2009;
25) Slimming Formula -- A Scientific Breakthrough -- GMP -- each box contains 3 pouches – Made in Japan. Recall # D-1791-2009;
26) Slim Fast 2 -- 32 capsules, 2 pouches per box – Made in Japan. Recall # D-1792-2009;
27) Slim Fast -- 100% Natural Ingredients -- 60 Capsules, 3 pouches per box -- Made in Japan. Recall # D-1793-2009;
28) Slim up -- 120 capsules per bottle, packaged in box -- Product Developed in Japan. Recall # D-1794-2009;
29) 7 Days Diet -- 100% Cut: 4in1 -- Firming & Slimming Formula -- 60 capsules per box, 3 pouches per box -- Made in Japan. Recall # D-1795-2009;
30) Perfect Slim Up! -- Royal Slimming Powerful Capsules -- 60 capsules per bottle, packaged in a box. Recall # D-1796-2009;
31) JM Fat Reducer -- 100% Natural Herbal Essence -- 120 capsules per box, each box contains 3 foil-like pouches - 60 capsules per pouch -- UPC unknown -- Reproduction in Japan. Recall # D-1797-2009;
32) SlimBurn -- 15 Minutes Overall Burning Fat -- 60 capsules per bottle, packaged in a box -- Made in Japan. Recall # D-1798-2009;
33) 21 Double Slim -- No. 1 -- 60 Capsules per bottle, packaged in a box. Recall # D-1799-2009;
34) Trim Plus 2 (Trim 2 Plus) -- 60 Capsules per bottle, packaged in a box. Recall # D-1800-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Universal A.B.C. Beauty Supply International, Inc., Brooklyn, NY, by letters dated December 31, 2008 and press release on April 20, 2009 followed by telephone and letters during the week of April 27, 2009. Firm initiated recall is ongoing.
REASON
Unapproved new drug, the dietary supplement was found to contain sibutramine, an FDA approved drug for weight loss based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide