Why it was recalled
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 Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns.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.
Product description
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 numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1009-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 22, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 37 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golean Detox US
Original FDA data
Every field from FDA enforcement report D-1009-2019, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 82246
- Address
- 4832 Central Ave
- Code information
- All lots remaining within expiry.
- Postal code
- 28205-5844
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1009-2019
- Classification
- Class I
- Recalling firm
- Golean Detox US
- Product quantity
- 37 boxes
- Termination date
- Jan 26, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 22, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 18, 2019