FDA Recall D-1047-2014
SS Wholesale Inc. dba Jobbers Wholesale · Paramount, CA
Class I — life-threatening Terminated 172 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
Recall record
- Recall number
D-1047-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- CA
- Recall initiated
- 2013-11-18
- Classified by FDA Center
- 2014-01-30
- FDA published
- 2014-02-05
- Terminated
- 2014-05-09
- Recalling firm
- SS Wholesale Inc. dba Jobbers Wholesale
- Firm location
- Paramount, CA