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Recall Observatory FDA recall evidence

Drug product

CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA

D-338-2013

December 17, 2012

Class I

Product summary

Firm
Performance Plus Marketing, Inc.
Event
Event 63916
Status
Terminated
Classification
Class I
Quantity
96,000 capsules.
Official record key
drug-enforcement:D-338-2013

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: Lot# 030112, Exp: 03/15

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