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Class I: serious health riskTerminated

Dolphin Intertrade Xiyouji Qingzhi Capsule Recall

XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box

Dolphin Intertrade Corporation · Miami, FL

Risk level
Class I
Reported by FDA
Apr 30, 2014
Recall ID
D-1250-2014
Check your lot numberHow we source this data

Summary

Dolphin Intertrade recalled Xiyouji Qingzhi Capsule starting May 20, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1250-2014 on Apr 30, 2014. Reason: 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. Status: Terminated.

Why it was recalled

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.

Product description

XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1250-2014
Classification
Class I
Status
Terminated
Recall initiated
May 20, 2013
FDA report date
Apr 30, 2014
Quantity
8 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Dolphin Intertrade Corporation

Original FDA data

Every field from FDA enforcement report D-1250-2014, exactly as published.

Show all FDA fields
City
Miami
State
FL
Status
Terminated
Country
United States
Event ID
65383
Address
11314 Sw 135th Ct
Code information
All Lots
Postal code
33186-4425
Report date
Apr 30, 2014
Product type
Drugs
Recall number
D-1250-2014
Classification
Class I
Recalling firm
Dolphin Intertrade Corporation
Product quantity
8 bottles
Termination date
Jun 29, 2016
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
Distribution pattern
Nationwide
Recall initiation date
May 20, 2013
Initial firm notification
E-Mail
Center classification date
Apr 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1250-2014, published Apr 30, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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