Why it was recalled
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Product description
KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
Lot numbers, UPCs & expiration codes
all lots
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-0297-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 6, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 132 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blue Square Market, Inc.
Original FDA data
Every field from FDA enforcement report D-0297-2016, exactly as published.
Show all FDA fields
- City
- North Huntingdon
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71912
- Address
- 2021 Clay Pike
- Address (line 2)
- Suite 1
- Code information
- all lots
- Postal code
- 15642-6319
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0297-2016
- Classification
- Class I
- Recalling firm
- Blue Square Market, Inc.
- Product quantity
- 132 boxes
- Termination date
- Oct 18, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 6, 2015
- Initial firm notification
- Press Release
- Center classification date
- Nov 17, 2015