← FDA ENFORCEMENT
D-0085-2025Class I

Boulla LLC

Recalling firm
Boulla LLC
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide within the United States
Firm state
CA
Product quantity
Unknown
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.