Multi-event May 2011 FDA Recall Drug by A B Nutrition, Inc.

This Multi-event Class II drug recall was voluntarily initiated by A B Nutrition, Inc. on May 27, 2011 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-196-2013 TERMINATED D-194-2013 TERMINATED D-195-2013 TERMINATED

Recall Number: D-196-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Initiated
05-27-2011
Reported
03-20-2013
Quantity
912 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
59001
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A B Nutrition, Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
In retail store located in TX and internet sales nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2013
Product Description About Product Description
Full technical description of the product.
ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090

Batch or Lot Expiration Information

Lot# 32000311

Recall Number: D-194-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Initiated
05-27-2011
Reported
03-20-2013
Quantity
2980 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
59001
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A B Nutrition, Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
In retail store located in TX and internet sales nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2013
Product Description About Product Description
Full technical description of the product.
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090

Batch or Lot Expiration Information

Lot# 33250311 Exp. 04/13

Recall Number: D-195-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Initiated
05-27-2011
Reported
03-20-2013
Quantity
509 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
59001
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A B Nutrition, Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
In retail store located in TX and internet sales nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2013
Product Description About Product Description
Full technical description of the product.
PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090

Batch or Lot Expiration Information

Lot# 33280311 Exp. 03/13