Friday, April 24, 2009

WARNING: FDA recalls Brooklyn diet pill company’s harmful over the counter supplements


Injury Lawyers News New York | New Jersey

New York’s Universal ABC Beauty Supply products contain illegal drugs.

New York, NY(NewYorkInjuryNews.com)–The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

A complete list of the 34 recalled products are can be found on the FDA’s website (see below) and includes SLIM FAST, 60 capsules, 3 pouches/box. Consumers should not consume any of the recalled products and may contact the diet supplement weight loss company for a full or partial refund of unused portions at their website. The FDA does not endorse this product or this product’s names and consumers may complain to the FDA’s main number 24 hours a day, 301-443-1240. Injured victims and concerned consumers can also file a report online at http://www.fda.gov/medwatch/index.html. If you have been injured by a defective product including an over the counter dietary supplement you may want to contact a New York personal injury lawyer.




fda.gov
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
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.

drugs.com

Meridia

Generic Name: sibutramine (oral) (sih BYOO tra meen)
Brand Names: Meridia

What is sibutramine?

Sibutramine affects chemicals in the body that are related to weight maintenance.

Sibutramine is used as a short-term supplement to diet and exercise in the treatment of obesity.

Sibutramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sibutramine?

Sibutramine has been reported to cause increased blood pressure in some patients. It is important to have your blood pressure and pulse monitored regularly while taking sibutramine.

Use caution when driving, operating machinery, or performing other hazardous activities. Sibutramine may cause dizziness, difficulty concentrating, or restlessness. If you experience these effects, avoid hazardous activities. Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), and migraine medicines.

What should I discuss with my healthcare provider before taking sibutramine?

Do not take sibutramine without first talking to your doctor if you
  • have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days;

  • are or have been depressed;

  • have bleeding problems;

  • have anorexia nervosa;

  • are taking an appetite suppressant;

  • have high blood pressure;

  • have heart disease, irregular heartbeats, congestive heart failure, or a history of stroke;

  • have epilepsy or another seizure disorder;

  • have gallstones;

  • have glaucoma;

  • have liver disease

  • have kidney disease.

You may not be able to take sibutramine, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Sibutramine may interact with other medicines and cause a condition called Serotonin Syndrome. This syndrome requires immediate medical attention and may include one or more of the following symptoms: anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and others. Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), or migraine medicines. Sibutramine is in the FDA pregnancy category C. This means that it is not known whether sibutramine will harm an unborn baby. Do not take sibutramine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sibutramine passes into breast milk. Do not take sibutramine without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of sibutramine have not been studied in children younger than 16 years of age.