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Recall Observatory FDA recall evidence

Drug product

AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.

D-1596-2014

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-1596-2014

Official wording

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

Code information: 2006-000926

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 AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.