Multi-event March 2013 FDA Recall Drug by Palmer Natural Products

This Multi-event Class II drug recall was voluntarily initiated by Palmer Natural Products on March 11, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Florida, Idaho, California and Hong Kong. This product can be ordered on line. and the recall is currently terminated.

Reported Recall Events

D-233-2013 TERMINATED D-232-2013 TERMINATED D-234-2013 TERMINATED D-235-2013 TERMINATED D-236-2013 TERMINATED D-230-2013 TERMINATED D-231-2013 TERMINATED

Recall Number: D-233-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
511 30 count bottles, 4103 100 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,

Batch or Lot Expiration Information

Lot# All lot codes.

Recall Number: D-232-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
250 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL

Batch or Lot Expiration Information

Lot# All lot codes.

Recall Number: D-234-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
4103 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .

Batch or Lot Expiration Information

Lot# All lot codes.

Recall Number: D-235-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
723 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826

Batch or Lot Expiration Information

Lot# All lot codes.

Recall Number: D-236-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826

Batch or Lot Expiration Information

Lot# All lot codes

Recall Number: D-230-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826

Batch or Lot Expiration Information

Lot# All lot codes.

Recall Number: D-231-2013

Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Initiated
03-11-2013
Reported
04-10-2013
Quantity
672 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64619
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.
Palmer Natural Products
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.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.

Batch or Lot Expiration Information

Lot# Lot HJLA