FDA Recall D-0297-2016
Blue Square Market, Inc. · North Huntingdon, PA
Class I — life-threatening Terminated 1169 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0297-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-08-06
- Classified by FDA Center
- 2015-11-17
- FDA published
- 2015-11-25
- Terminated
- 2018-10-18
- Recalling firm
- Blue Square Market, Inc.
- Firm location
- North Huntingdon, PA