FDA Recall D-1009-2019

Golean Detox US · Charlotte, NC

Class I — life-threatening Terminated 704 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 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 / code: All lots remaining within expiry.

Quantity: 37 boxes

Reason for recall

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 Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns.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.

Recall record

Recall number: D-1009-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA.
Recall initiated: 2019-02-22
Classified by FDA Center: 2019-03-18
FDA published: 2019-03-20
Terminated: 2021-01-26
Recalling firm: Golean Detox US
Firm location: Charlotte, NC

‹ All recalls