FDA Recall D-333-2013

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

libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.

Lot / code: 1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14.

Quantity: 686,000 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-333-2013
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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