Drug Enforcement D-0085-2025

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

Status

Ongoing

Classification

Class I

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Product quantity
Unknown
Reason for recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Boulla LLC
Address
2108 N ST #7929

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0085-2025
Event ID
95714
Recall initiation date
November 4, 2024
Center classification date
December 2, 2024
Code info
Lot #: YZM240406, Exp: 04/05/2027
More code info
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