Multi-event August 2015 FDA Recall Drug by Novacare, Llc

This Multi-event Class I drug recall was voluntarily initiated by Novacare, Llc on August 24, 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-0971-2016 TERMINATED D-0973-2016 TERMINATED D-0970-2016 TERMINATED D-0961-2016 TERMINATED D-0972-2016 TERMINATED D-0968-2016 TERMINATED D-0963-2016 TERMINATED D-0969-2016 TERMINATED D-0966-2016 TERMINATED D-0962-2016 TERMINATED D-0964-2016 TERMINATED D-0967-2016 TERMINATED D-0965-2016 TERMINATED

Recall Number: D-0971-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Batch or Lot Expiration Information

Lot# UPC 859613252258

Recall Number: D-0973-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Xcellerator (product not labeled)

Batch or Lot Expiration Information

Lot# unknown

Recall Number: D-0970-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Batch or Lot Expiration Information

Lot# UPC 859613274229

Recall Number: D-0961-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.

Batch or Lot Expiration Information

Lot# UPC 853002003025

Recall Number: D-0972-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

Batch or Lot Expiration Information

Lot# UPC 859613638496

Recall Number: D-0968-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

Batch or Lot Expiration Information

Lot# UPC 637687019003

Recall Number: D-0963-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.

Batch or Lot Expiration Information

Lot# unknown

Recall Number: D-0969-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

Batch or Lot Expiration Information

Lot# UPC 637687019133

Recall Number: D-0966-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.

Batch or Lot Expiration Information

Lot# UPC 020025500095

Recall Number: D-0962-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.

Batch or Lot Expiration Information

Lot# UPC 793573902665

Recall Number: D-0964-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.

Batch or Lot Expiration Information

Lot# UPC 637687114593

Recall Number: D-0967-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
TruTrim (product not labeled)

Batch or Lot Expiration Information

Lot# unknown

Recall Number: D-0965-2016

Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Initiated
08-24-2015
Reported
06-15-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71989
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.
Novacare, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2017
Product Description About Product Description
Full technical description of the product.
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.

Batch or Lot Expiration Information

Lot# unknown