FDA Recall D-336-2013

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

Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;

Lot / code: (1 count) Lot# 01MJ0712, (1 count) 01MM0211 Exp: 07/15; (5 count) Lot# 05M0912, Exp: 10/15;

Quantity: 219,000 capsules.

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-336-2013
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

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