Multi-event December 2014 FDA Recall Drug by Anabolic Science Labs, Llc

This Multi-event Class I drug recall was voluntarily initiated by Anabolic Science Labs, Llc on December 12, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda - these products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0984-2015 TERMINATED D-0986-2015 TERMINATED D-0985-2015 TERMINATED D-0990-2015 TERMINATED D-0988-2015 TERMINATED D-0989-2015 TERMINATED D-0987-2015 TERMINATED

Recall Number: D-0984-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
3,638 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0986-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
515 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0985-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
1,479 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0990-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
22,353 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0988-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
12,166 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0989-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
10,829 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-0987-2015

Reason for Recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Initiated
12-12-2014
Reported
05-13-2015
Quantity
3,808 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70317
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.
Anabolic Science Labs, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide and Singapore
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Batch or Lot Expiration Information

Lot# All lots