Recall: Golean DETOX Capsules
On 2019-02-25, the FDA announced that Golean Detox USA is conducting a recall on DETOX Capsules due to possible undeclared sibutramine, phenolphthalein. The recalled products were sold under the brand name(s) Golean during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 5 drugs recalls due to potential undeclared ingredients, including indian herb, male enhancement nutritional supplement and more. Additionally, there have been 15 drug and medical device recalls due to other health hazards as well as 83 food recalls.
Company Contact Information:
Name: Golean Detox USA
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: DETOX Capsules
Brand Name(s): Golean
Reason for Recall: Undeclared Sibutramine and Phenolphthalein
Official Recall Date: 2019-02-25
Additional information provided by the FDA.gov:
Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.