Recall D-0084-2025

US Class I Ongoing · initiated 2024-11-04

Recalling firm

Boulla LLC, CA

Product

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

Reason for recall

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

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