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Class I: serious health riskTerminated

MS Bionic MegaJex Herbal Supplement Recall

MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 c…

MS Bionic · Gardena, CA

Risk level
Class I
Reported by FDA
Feb 22, 2017
Recall ID
D-0472-2017
Check your lot numberHow we source this data

Summary

MS Bionic recalled MegaJex Herbal Supplement starting Nov 30, 2016. The FDA classified it as Class I (serious health risk) and published enforcement report D-0472-2017 on Feb 22, 2017. Reason: Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED). Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)

Product description

MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA

Lot numbers, UPCs & expiration codes

All Lots exp. date 12/2019

Where it was sold

CA

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-0472-2017
Classification
Class I
Status
Terminated
Recall initiated
Nov 30, 2016
FDA report date
Feb 22, 2017
Quantity
100 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
MS Bionic

Original FDA data

Every field from FDA enforcement report D-0472-2017, exactly as published.

Show all FDA fields
City
Gardena
State
CA
Status
Terminated
Country
United States
Event ID
75753
Address
447 E Gardena Blvd
Code information
All Lots exp. date 12/2019
Postal code
90248-2913
Report date
Feb 22, 2017
Product type
Drugs
Recall number
D-0472-2017
Classification
Class I
Recalling firm
MS Bionic
Product quantity
100 bottles
Termination date
Jun 1, 2017
Reason for recall
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Voluntary / mandated
Voluntary: Firm initiated
Product description
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Distribution pattern
CA
Recall initiation date
Nov 30, 2016
Initial firm notification
Press Release
Center classification date
Feb 13, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0472-2017, published Feb 22, 2017. 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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