Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
Product description
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Lot numbers, UPCs & expiration codes
Lot #: JBP-L-1270-70, Exp 12/16
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-1046-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 18, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 2,395 blister packs total for all products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SS Wholesale Inc. dba Jobbers Wholesale
Original FDA data
Every field from FDA enforcement report D-1046-2014, exactly as published.
Show all FDA fields
- City
- Paramount
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66840
- Address
- 16101 Garfield Ave
- Code information
- Lot #: JBP-L-1270-70, Exp 12/16
- Postal code
- 90723
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1046-2014
- Classification
- Class I
- Recalling firm
- SS Wholesale Inc. dba Jobbers Wholesale
- Product quantity
- 2,395 blister packs total for all products
- Termination date
- May 9, 2014
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
- Distribution pattern
- CA
- Recall initiation date
- Nov 18, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 30, 2014