Google+ Badge

Tuesday, February 10, 2015

Supplements Recalled Because of Undeclared Drug Ingredients

Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.suppliments
Product Name
Bottle Color
Label
# Capsules
UPC
Lot
Expiration
EDGE Amplified Weight Release
White
Purple label
60
852175004174
ALL
iNDiGO
White
Dark blue label
60
852175004044
000034
4/10/2017
AMPD Gold Bee Pollen
White
Black label
60
852175004181
ALL
BtRim Max
White
Dark Red label
60
852175004068
00002
4/27/2017
iNSANE Bee Pollen
White
Bright Red label
60
852175004082
0000:02
6/20/2017
FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended.
Fluoxetine is an SSRI with potentially life threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine containing dietary supplement product.
In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.
The products were distributed nationwide via the internet and retail stores.
Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.
Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Label, EDGE Amplified Weight Release dietary supplement
Label, AMPD Gold Bee Pollen dietary supplement
Label, iNSANE Bee Pollen dietary supplement
Signature_SKINNY_Indigo

No comments:

Post a Comment