Charlotte, NC, United States
Golean Detox US recalls
1 recall recorded since 2018, most recently on 22 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 22 February 2019
- Terminated
- 26 January 2021
- Reason
- 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 Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns.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.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1009-2019
- 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, Vie
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.