FDA Recall D-335-2013

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

BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536

Lot / code: (1 count)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15

Quantity: 1,000 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-335-2013
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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