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Class I: serious health riskTerminated

Performance Plus Marketing Mojo nights SUPREME Capsules Recall

Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count bliste…

Performance Plus Marketing, Inc. · Commerce, CA

Risk level
Class I
Reported by FDA
May 22, 2013
Recall ID
D-337-2013
Check your lot numberHow we source this data

Summary

Performance Plus Marketing recalled Mojo nights SUPREME Capsules starting Dec 17, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-337-2013 on May 22, 2013. Reason: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs. Status: Terminated.

Why it was recalled

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Product description

Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL

Lot numbers, UPCs & expiration codes

Lot# 01MJS0712, Exp 07/15.

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-337-2013
Classification
Class I
Status
Terminated
Recall initiated
Dec 17, 2012
FDA report date
May 22, 2013
Quantity
70,000 capsules.
Recall type
Voluntary: Firm initiated
Recalling firm
Performance Plus Marketing, Inc.

Original FDA data

Every field from FDA enforcement report D-337-2013, exactly as published.

Show all FDA fields
City
Commerce
State
CA
Status
Terminated
Country
United States
Event ID
63916
Address
5560 E 61st St
Code information
Lot# 01MJS0712, Exp 07/15.
Postal code
90040-3406
Report date
May 22, 2013
Product type
Drugs
Recall number
D-337-2013
Classification
Class I
Recalling firm
Performance Plus Marketing, Inc.
Product quantity
70,000 capsules.
Termination date
Nov 14, 2013
Reason for recall
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
Distribution pattern
Nationwide
Recall initiation date
Dec 17, 2012
Initial firm notification
Telephone
Center classification date
May 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-337-2013, 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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