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Recall Observatory FDA recall evidence

Drug product

libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.

D-332-2013

December 17, 2012

Class I

Product summary

Firm
Performance Plus Marketing, Inc.
Event
Event 63916
Status
Terminated
Classification
Class I
Quantity
610,000 capsules
Official record key
drug-enforcement:D-332-2013

Official wording

Reason: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Code information: 1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs