Multi-event February 2012 FDA Recall Drug by Www.vitaminbestbuy.com

This Multi-event Class I drug recall was voluntarily initiated by Www.vitaminbestbuy.com on February 23, 2012 for the product Drug. The FDA reported the reason for recall as marketed without an approved anda/nda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1700-2012 TERMINATED D-1699-2012 TERMINATED D-1698-2012 TERMINATED

Recall Number: D-1700-2012

Reason for Recall
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Initiated
02-23-2012
Reported
10-03-2012
Quantity
52 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61256
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.
www.vitaminbestbuy.com
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2018
Product Description About Product Description
Full technical description of the product.
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY

Batch or Lot Expiration Information

Lot# All lots.

Recall Number: D-1699-2012

Reason for Recall
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Initiated
02-23-2012
Reported
10-03-2012
Quantity
69 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61256
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.
www.vitaminbestbuy.com
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2018
Product Description About Product Description
Full technical description of the product.
Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328

Batch or Lot Expiration Information

Lot# All lots.

Recall Number: D-1698-2012

Reason for Recall
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Initiated
02-23-2012
Reported
10-03-2012
Quantity
550 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61256
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.
www.vitaminbestbuy.com
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2018
Product Description About Product Description
Full technical description of the product.
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet

Batch or Lot Expiration Information

Lot# All lots.