D-378-2014 Class I Terminated
FDA drug recall D-378-2014 was initiated by Fabscout Entertainment, Inc on August 14, 2013 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil The recall status is terminated (terminated February 10, 2021). Affected quantity: 18 blister packs of one capsule each.
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2013
- Initiation Date
- August 14, 2013
- Termination Date
- February 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 blister packs of one capsule each
Product Description
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Reason for Recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Distribution Pattern
CA, FL and UT
Code Information
All Lots