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Class I: serious health riskTerminated

Pure Edge Nutrition Bella Vi BTrim MAX Dietary Supplement Recall

Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www

Pure Edge Nutrition · Toms River, NJ

Risk level
Class I
Reported by FDA
Jun 18, 2014
Recall ID
D-1366-2014
Check your lot numberHow we source this data

Summary

Pure Edge Nutrition recalled Bella Vi BTrim MAX Dietary Supplement starting Oct 10, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1366-2014 on Jun 18, 2014. Reason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

Product description

Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Lot numbers, UPCs & expiration codes

lot # BTX13 EXP: 2015/08/15

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-1366-2014
Classification
Class I
Status
Terminated
Recall initiated
Oct 10, 2013
FDA report date
Jun 18, 2014
Quantity
unknown
Recall type
Voluntary: Firm initiated
Recalling firm
Pure Edge Nutrition

Original FDA data

Every field from FDA enforcement report D-1366-2014, exactly as published.

Show all FDA fields
City
Toms River
State
NJ
Status
Terminated
Country
United States
Event ID
67810
Address
1182 Fischer Blvd Ste 3
Code information
lot # BTX13 EXP: 2015/08/15
Postal code
08753-3093
Report date
Jun 18, 2014
Product type
Drugs
Recall number
D-1366-2014
Classification
Class I
Recalling firm
Pure Edge Nutrition
Product quantity
unknown
Termination date
Oct 7, 2016
Reason for recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Voluntary / mandated
Voluntary: Firm initiated
Product description
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Distribution pattern
Nationwide
Recall initiation date
Oct 10, 2013
Initial firm notification
E-Mail
Center classification date
Jun 12, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1366-2014, published Jun 18, 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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