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在全国范围内自愿召回含未申报药物成分的膳食补充剂产品

Voluntary nationwide recall of dietary supplement products found to contain an undeclared drug ingredient

2009-05-05 【发表评论】
中文 | ENGLISH | 打印| 推荐给好友


ST LOUIS (MD Consult) - Universal ABC Beauty Supply International, Inc, of Brooklyn, NY, has been informed by the US 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 are unknown.

The FDA said these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients. It also 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:

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

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 for the safety of consumers. The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers.

Consumers should not use 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 returns. Consumers with questions should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00
PM through 6 PM EDT.
 

圣路易斯(MD Consult)——美国食品药物管理局(FDA)已向纽约布鲁克林的Universal ABC Beauty Supply国际公司发出一份通报,称 FDA实验室分析发现该公司分销的膳食补充剂含有未经申报的西布曲明,后者为FDA批准的药物,可通过抑制食欲达到减肥疗效。

 

而这些膳食补充剂本不该含有西布曲明。美国FDA尚未批准此类膳食补充剂产品,因此其安全性和有效性目前仍无从得知。


FDA
指出,这些产品对消费者构成了威胁,因为众所周知,在某些患者中西布曲明可显著升高血压和/或脉搏次数。它还可能对有冠状动脉疾病、充血性心力衰竭、心律不齐或中风病史的患者有很大的风险。

 

所有批次的下列膳食补充剂产品正在召回:

1ProSlim Plus60 /瓶,盒装
2
3 DAYS fit60 /瓶,盒装
3
EIGHT FACTOR DIET60/袋,3 /
4
24hours Diet60
5
Slim 3in1 M-18 ROYAL DIET90/袋,3 /
6
3X SLIMMING POWER60 /瓶,盒装
7
Extrim Plus 24 Hours RE-BURN Formula60
8
Slim 3in1 EXTRA SLIM FORMULA90/袋,3 /
9
Slim 3in1 EXTRA SLIM WAIST FORMULA90/袋,3 /
10
SLIM EXPRESS 360° C
11
SLIM EXPRESS 4in160 /瓶,盒装
12
ROYAL SLIMMING FORMULA60 /瓶,盒装
13
BODY CREATOR90/袋,3 /
14
Slim Waistline (说明书以中文书写)
15
BODY SHAPING90/袋,3 /
16
PERFECT SLIM90/袋,3 /
17
Perfect Slim 100% Natural Herbal Essence
18
IMELDA Perfect Slim
19
Slim Waist Formula32/袋,2/
20
Super Slimming60 /瓶,盒装
21
2 DAY DIET
22
Powerful Slim
23
BODY SHAPING
24
SUPER FAT BURNER60 /瓶,盒装
25
SLIMMING FORMULA
26
SLIM FAST 232/袋,2/
27
SLIM FAST60/袋,3/
28
Slim up, 120 capsules, bottle in box
29
7 DAYS DIET60/袋,3/
30
Perfect Slim Up60 /瓶,盒装
31
JM Fat Reducer
32
SlimBurn
33
21 Double SLIM
34
TRIM PLUS 2

上述产品可能有不同的条形码。

 

迄今为止,使用该公司的此类产品尚没有致病或致伤的相关报告。

 

为保证消费者的安全,Universal ABC Beauty Supply国际公司致力于提供产品的准确信息,目前所采取的召回措施为自愿行为。该公司已停止销售这些产品。由此给客户带来的不便,公司表示致以最诚挚的歉意。

 

消费者不应继续使用上述产品,退回未使用产品可以获得全额退款,使用过的产品则可获得部分退款。经销商请致电718-891-6888或通过电子邮件universalabc@aol.com联系Sandra Tan以获取进一步的召回信息。消费者如有疑问,请在每周一至周五美国东部时间中午12点到下午6点致电718-891-6888咨询Sandra Tan


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 王燕燕 王曙

上海交通大学附属瑞金医院内分泌科

患者,女,69岁。2009年1月无明显诱因下出现乏力,当时程度较轻,未予以重视。2009年3月患者乏力症状加重,尿色逐渐加深,大便习惯改变,颜色变淡。4月18日入我院感染科治疗,诉轻度头晕、心慌,体重减轻10kg。无肝区疼痛,无发热,无腹痛、腹泻、腹胀、里急后重,无恶性、呕吐等。入院半月前于外院就诊,查肝功能:ALT 601IU/L,AST 785IU/L,TBIL 97.7umol/L,白蛋白 41g/L,甲状腺功能:游离T3 30.6pmol/L,游离T4 51.9pmol/L,心电图示快速房颤。
 

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