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Recall Observatory FDA recall evidence

Drug product

LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language

D-0570-2018

March 07, 2017

Class I

Product summary

Firm
A&H Focal Inc.
Event
Event 76644
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-0570-2018

Official wording

Reason: Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Code information: All Lots

Distribution pattern: NY and NJ through six retail stores named "Asian Food Markets"

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.