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Recall Observatory FDA recall evidence

Drug product

Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012

D-1600-2014

March 28, 2014

Class I

Product summary

Firm
Nova Products, Inc.
Event
Event 67860
Status
Terminated
Classification
Class I
Quantity
Unknown
Official record key
drug-enforcement:D-1600-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

Code information: Lot# 13051012

Distribution pattern: Nationwide to retailers and distributors

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.