Products found to contain undeclared medicines
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| The United States: Lucy's Weight Loss System issues voluntary nationwide recall of Pink Bikini dietary supplement due to undeclared diclofenac |
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Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level. Pink Bikini has been found positive for diclofenac after FDA sampling and testing.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. Diclofenac can increase the risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. For those that are pregnant, taking diclofenac during the last three months of pregnancy may harm the unborn baby. This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. Lucy's Weight Loss System has not received any complaints to date. Lucy's Weight Loss System has not received any reports of adverse events related to this recall to date.
The product is used as a weight loss dietary supplement and is packaged in clear bottle in white powder capsules. The affected Pink Bikini and lots include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm476494.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, December 10, 2015
Issued at HKT 15:30
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