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Class I: serious health riskTerminated

Dolphin Intertrade JaDera Recall

JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

Dolphin Intertrade Corporation · Miami, FL

Risk level
Class I
Reported by FDA
Apr 30, 2014
Recall ID
D-1249-2014
Check your lot numberHow we source this data

Summary

Dolphin Intertrade recalled JaDera starting May 20, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1249-2014 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

JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

Lot numbers, UPCs & expiration codes

Manufacturing Codes: 10.06.2011 Exp. 09.06.2013

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-1249-2014
Classification
Class I
Status
Terminated
Recall initiated
May 20, 2013
FDA report date
Apr 30, 2014
Quantity
998 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Dolphin Intertrade Corporation

Original FDA data

Every field from FDA enforcement report D-1249-2014, 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
Manufacturing Codes: 10.06.2011 Exp. 09.06.2013
Postal code
33186-4425
Report date
Apr 30, 2014
Product type
Drugs
Recall number
D-1249-2014
Classification
Class I
Recalling firm
Dolphin Intertrade Corporation
Product quantity
998 boxes
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
JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
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-1249-2014, 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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