Why it was recalled
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Product description
Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
Lot numbers, UPCs & expiration codes
Lot# 13051012
Where it was sold
Nationwide to retailers and distributors
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-1600-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 28, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nova Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1600-2014, exactly as published.
Show all FDA fields
- City
- Aston
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67860
- Address
- 5 Mount Pleasant Rd
- Code information
- Lot# 13051012
- Postal code
- 19014-1407
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1600-2014
- Classification
- Class I
- Recalling firm
- Nova Products, Inc.
- Product quantity
- Unknown
- Termination date
- Aug 6, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
- Distribution pattern
- Nationwide to retailers and distributors
- Recall initiation date
- Mar 28, 2014
- Initial firm notification
- Press Release
- Center classification date
- Sep 18, 2014