FDA Recall D-1169-2014
Fabscout Entertainment, Inc · Ft Lauderdale, FL
Class I — life-threatening Terminated 2288 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Recall record
- Recall number
D-1169-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and France
- Recall initiated
- 2013-06-27
- Classified by FDA Center
- 2014-03-20
- FDA published
- 2014-03-26
- Terminated
- 2019-10-02
- Recalling firm
- Fabscout Entertainment, Inc
- Firm location
- Ft Lauderdale, FL