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