Multi-event January 2015 FDA Recall Drug by Detox Transforms

This Multi-event Class I drug recall was voluntarily initiated by Detox Transforms on January 25, 2015 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0978-2015 TERMINATED D-0977-2015 TERMINATED D-0980-2015 TERMINATED D-0979-2015 TERMINATED D-0981-2015 TERMINATED

Recall Number: D-0978-2015

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Initiated
01-25-2015
Reported
05-13-2015
Quantity
175 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70444
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Detox Transforms
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WV who distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.

Batch or Lot Expiration Information

Lot# Lot: 000034, Exp 04/10/17

Recall Number: D-0977-2015

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Initiated
01-25-2015
Reported
05-13-2015
Quantity
150 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70444
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Detox Transforms
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WV who distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.

Batch or Lot Expiration Information

Lot# Lots: ALL

Recall Number: D-0980-2015

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Initiated
01-25-2015
Reported
05-13-2015
Quantity
173 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70444
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Detox Transforms
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WV who distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.

Batch or Lot Expiration Information

Lot# Lot: 00002, Exp 04/27/17

Recall Number: D-0979-2015

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Initiated
01-25-2015
Reported
05-13-2015
Quantity
150 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70444
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Detox Transforms
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WV who distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.

Batch or Lot Expiration Information

Lot# Lots: ALL

Recall Number: D-0981-2015

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Initiated
01-25-2015
Reported
05-13-2015
Quantity
200 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70444
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Detox Transforms
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WV who distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.

Batch or Lot Expiration Information

Lot# Lot: 0000:02, Exp 06/20/17