Multi-event May 2013 FDA Recall Drug by Dolphin Intertrade Corporation

This Multi-event Class I drug recall was voluntarily initiated by Dolphin Intertrade Corporation on May 20, 2013 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-1250-2014 TERMINATED D-1249-2014 TERMINATED

Recall Number: D-1250-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Initiated
05-20-2013
Reported
04-30-2014
Quantity
8 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65383
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.
Dolphin Intertrade Corporation
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.
06-29-2016
Product Description About Product Description
Full technical description of the product.
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-1249-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Initiated
05-20-2013
Reported
04-30-2014
Quantity
998 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65383
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.
Dolphin Intertrade Corporation
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.
06-29-2016
Product Description About Product Description
Full technical description of the product.
JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

Batch or Lot Expiration Information

Lot# Manufacturing Codes: 10.06.2011 Exp. 09.06.2013