FDA recall D-0297-2016
Blue Square Market, Inc. · Class I · drug
Product
KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
Reason for recall
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2015-08-06
- Report date
- 2015-11-25
- Termination date
- 2018-10-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- North Huntingdon, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2016