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Recall Observatory FDA recall evidence

Drug product

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

D-0085-2025

November 04, 2024

Class I

Product summary

Firm
Boulla LLC
Event
Event 95714
Status
Ongoing
Classification
Class I
Quantity
Unknown
Official record key
drug-enforcement:D-0085-2025

Official wording

Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Code information: Lot #: YZM240406, Exp: 04/05/2027

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.