D-1170-2014 Class I Terminated
FDA drug recall D-1170-2014 was initiated by Fabscout Entertainment, Inc on June 27, 2013 and is designated Class I. 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. The recall status is terminated (terminated October 2, 2019).
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
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (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