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Class I: serious health riskTerminated

Reesna Fuel Up High Octane Recall

FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottl…

Reesna, Inc · Canoga Park, CA

Risk level
Class I
Reported by FDA
Jun 15, 2016
Recall ID
D-0960-2016
Check your lot numberHow we source this data

Summary

Reesna recalled Fuel Up High Octane starting Dec 11, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-0960-2016 on Jun 15, 2016. Reason: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.

Product description

FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM

Lot numbers, UPCs & expiration codes

Exp. 12/18

Where it was sold

Nationwide and United Kingdom

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-0960-2016
Classification
Class I
Status
Terminated
Recall initiated
Dec 11, 2015
FDA report date
Jun 15, 2016
Quantity
7,250 capsules
Recall type
Voluntary: Firm initiated
Recalling firm
Reesna, Inc

Original FDA data

Every field from FDA enforcement report D-0960-2016, exactly as published.

Show all FDA fields
City
Canoga Park
State
CA
Status
Terminated
Country
United States
Event ID
72830
Address
7921 Canoga Ave Ste I
Code information
Exp. 12/18
Postal code
91304-5021
Report date
Jun 15, 2016
Product type
Drugs
Recall number
D-0960-2016
Classification
Class I
Recalling firm
Reesna, Inc
Product quantity
7,250 capsules
Termination date
Jun 9, 2016
Reason for recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Voluntary / mandated
Voluntary: Firm initiated
Product description
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Distribution pattern
Nationwide and United Kingdom
Recall initiation date
Dec 11, 2015
Initial firm notification
Telephone
Center classification date
Jun 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0960-2016, published Jun 15, 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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