Reported Mar 20, 2019 · Terminated
Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G…
Golean Detox US
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Golean Detox US · 4832 Central Ave · Charlotte, NC · 28205-5844
Is this the product you have?
- Golean DETOX capsules, 14
- Net
56 g14 packets containing 2 capsules per packet28-count capsules per boxMAT XI S.G CoLTD
- Head officeJ29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam
- Manufactory148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013
- Lot codes and dates
- All lots remaining within expiry.
- Amount recalled
- 37 boxes
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns.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 US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Using this product could cause serious injury, illness or death — stop using it now.
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