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Class I: serious health riskTerminated

Slim Beauty Dream Body Slimming Capsule Recall

Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%

Slim Beauty USA · Kearney, NE

Risk level
Class I
Reported by FDA
Apr 16, 2014
Recall ID
D-1222-2014
Check your lot numberHow we source this data

Summary

Slim Beauty recalled Dream Body Slimming Capsule starting Dec 10, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1222-2014 on Apr 16, 2014. Reason: Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.

Product description

Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).

Lot numbers, UPCs & expiration codes

Lot # 20130328, Exp 3/27/15

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-1222-2014
Classification
Class I
Status
Terminated
Recall initiated
Dec 10, 2013
FDA report date
Apr 16, 2014
Quantity
3 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Slim Beauty USA

Original FDA data

Every field from FDA enforcement report D-1222-2014, exactly as published.

Show all FDA fields
City
Kearney
State
NE
Status
Terminated
Country
United States
Event ID
67260
Address
503 E 23rd St
Code information
Lot # 20130328, Exp 3/27/15
Postal code
68847
Report date
Apr 16, 2014
Product type
Drugs
Recall number
D-1222-2014
Classification
Class I
Recalling firm
Slim Beauty USA
Product quantity
3 bottles
Termination date
Mar 14, 2017
Reason for recall
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
Distribution pattern
Nationwide
Recall initiation date
Dec 10, 2013
Initial firm notification
E-Mail
Center classification date
Apr 7, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1222-2014, published Apr 16, 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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