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Recall Observatory FDA recall evidence

Drug product

Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4

D-0354-2021

March 30, 2021

Class II

Product summary

Firm
Na Na Collection
Event
Event 87653
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0354-2021

Official wording

Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Code information: Lot #: GATCO 1805, Exp. Date 12/30/2024 Serial # 715122050894

Distribution pattern: Nationwide with the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.