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Class I: serious health riskTerminated

Evol Nutrition Mojo Nights Recall

Mojo Nights, 1 capsule

Evol Nutrition · Kennesaw, GA

Risk level
Class I
Reported by FDA
May 22, 2013
Recall ID
D-327-2013
Check your lot numberHow we source this data

Summary

Evol Nutrition recalled Mojo Nights starting Aug 23, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-327-2013 on May 22, 2013. Reason: Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Status: Terminated.

Why it was recalled

Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.

Product description

Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351

Lot numbers, UPCs & expiration codes

All lots, no Expiry

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-327-2013
Classification
Class I
Status
Terminated
Recall initiated
Aug 23, 2012
FDA report date
May 22, 2013
Quantity
1000 blister packs (total both products)
Recall type
Voluntary: Firm initiated
Recalling firm
Evol Nutrition

Original FDA data

Every field from FDA enforcement report D-327-2013, exactly as published.

Show all FDA fields
City
Kennesaw
State
GA
Status
Terminated
Country
United States
Event ID
63232
Address
1075 Cobb International Pl NW Ste F
Code information
All lots, no Expiry
Postal code
30152-7665
Report date
May 22, 2013
Product type
Drugs
Recall number
D-327-2013
Classification
Class I
Recalling firm
Evol Nutrition
Product quantity
1000 blister packs (total both products)
Termination date
Jul 22, 2013
Reason for recall
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
Distribution pattern
Nationwide
Recall initiation date
Aug 23, 2012
Initial firm notification
Press Release
Center classification date
May 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-327-2013, published May 22, 2013. 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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