PlainRecalls
FDA Drug Critical Class I Terminated

ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.

Reported: May 28, 2014 Initiated: January 9, 2014 #D-1339-2014

Product Description

ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.

Reason for Recall

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Details

Units Affected
57 boxes
Distribution
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.. Recalled by Schindele Enterprises dba Midwest Wholesale. Units affected: 57 boxes.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2014. Severity: Critical. Recall number: D-1339-2014.