D-1169-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 26, 2014
- Initiation Date
- June 27, 2013
- Termination Date
- October 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Distribution Pattern
Nationwide and France
Code Information
All lots