D-0104-2018 Class I Terminated
FDA drug recall D-0104-2018 was initiated by Gadget Island, Inc on September 15, 2017 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. The recall status is terminated (terminated December 4, 2018). Affected quantity: 89 1-capsule packets.
Recall Details
- Product Type
- Drugs
- Report Date
- December 13, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- December 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 1-capsule packets
Product Description
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Reason for Recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Distribution Pattern
Nationwide in the USA
Code Information
Lot# NSS050888, EXP 05-2018