Drug product

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

D-1339-2014

January 09, 2014

Class I

Product summary

Firm: Schindele Enterprises dba Midwest Wholesale
Event: Event 67228
Status: Terminated
Classification: Class I
Quantity: 57 boxes
Official record key: drug-enforcement:D-1339-2014

Official wording

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

Code information: Lot 0512058, Exp. 05/16

Distribution pattern: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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