PlainRecalls
FDA Drug Critical Class I Terminated

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

Reported: December 13, 2017 Initiated: September 15, 2017 #D-0105-2018

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.

Details

Recalling Firm
Gadget Island, Inc
Units Affected
273 1-capsule packets
Distribution
Nationwide in the USA
Location
Newark, CA

Frequently Asked Questions

What product was recalled?
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056. Recalled by Gadget Island, Inc. Units affected: 273 1-capsule packets.
Why was this product recalled?
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 13, 2017. Severity: Critical. Recall number: D-0105-2018.