Recalls / Class I
Class ID-337-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
- Affected lot / code info
- Lot# 01MJS0712, Exp 07/15.
Why it was recalled
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Recalling firm
- Firm
- Performance Plus Marketing, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 5560 E 61st St, Commerce, California 90040-3406
Distribution
- Quantity
- 70,000 capsules.
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-17
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2013-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-337-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.