Why it was recalled
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
Product description
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
Lot numbers, UPCs & expiration codes
Lot L08108, Exp 06/15
Where it was sold
Nationwide
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-323-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 22, 2012
- FDA report date
- May 22, 2013
- Quantity
- 40,480 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- D& S Herbals, LLC
Original FDA data
Every field from FDA enforcement report D-323-2013, exactly as published.
Show all FDA fields
- City
- Woodbridge
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64190
- Address
- 1413 Dutchess Ln
- Code information
- Lot L08108, Exp 06/15
- Postal code
- 07095-3855
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-323-2013
- Classification
- Class I
- Recalling firm
- D& S Herbals, LLC
- Product quantity
- 40,480 blister packs
- Termination date
- Aug 12, 2013
- Reason for recall
- Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 22, 2012
- Initial firm notification
- Press Release
- Center classification date
- May 16, 2013