D-0105-2018 Class I Terminated
FDA drug recall D-0105-2018 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: 273 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
- 273 1-capsule packets
Product Description
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
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
All Lots