D-1339-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- January 9, 2014
- Termination Date
- February 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 boxes
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.
Distribution Pattern
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Code Information
Lot 0512058, Exp. 05/16