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Class I: serious health riskTerminated

Centro Naturista Smart Lipo Dietary Supplement capsules Recall

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Di…

Centro Naturista · Dallas, TX

Risk level
Class I
Reported by FDA
Jun 1, 2016
Recall ID
D-0877-2016
Check your lot numberHow we source this data

Summary

Centro Naturista recalled Smart Lipo Dietary Supplement capsules starting Jun 3, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-0877-2016 on Jun 1, 2016. Reason: Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. Status: Terminated.

Why it was recalled

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

Product description

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

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-0877-2016
Classification
Class I
Status
Terminated
Recall initiated
Jun 3, 2015
FDA report date
Jun 1, 2016
Quantity
Unknown
Recall type
Voluntary: Firm initiated
Recalling firm
Centro Naturista

Original FDA data

Every field from FDA enforcement report D-0877-2016, exactly as published.

Show all FDA fields
City
Dallas
State
TX
Status
Terminated
Country
United States
Event ID
71401
Address
14211 Coit Rd
Address (line 2)
Ste H
Code information
All lots
Postal code
75254-2862
Report date
Jun 1, 2016
Product type
Drugs
Recall number
D-0877-2016
Classification
Class I
Recalling firm
Centro Naturista
Product quantity
Unknown
Termination date
Mar 30, 2017
Reason for recall
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Distribution pattern
Nationwide
Recall initiation date
Jun 3, 2015
Initial firm notification
Press Release
Center classification date
May 26, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0877-2016, published Jun 1, 2016. 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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