FDA Recall D-338-2013
Performance Plus Marketing, Inc. · Commerce, CA
Class I — life-threatening Terminated 332 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
Reason for recall
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Recall record
- Recall number
D-338-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide
- Recall initiated
- 2012-12-17
- Classified by FDA Center
- 2013-05-16
- FDA published
- 2013-05-22
- Terminated
- 2013-11-14
- Recalling firm
- Performance Plus Marketing, Inc.
- Firm location
- Commerce, CA