Recalls / Class I
Class ID-1169-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Affected lot / code info
- All lots
Why it was recalled
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.
Recalling firm
- Firm
- Fabscout Entertainment, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1458 NW 23rd Ave, Ft Lauderdale, Florida 33311-5147
Distribution
- Distribution pattern
- Nationwide and France
Timeline
- Recall initiated
- 2013-06-27
- FDA classified
- 2014-03-20
- Posted by FDA
- 2014-03-26
- Terminated
- 2019-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1169-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.