D-0084-2025 Class I Ongoing

Recalled by Boulla LLC — Sacramento, CA

Recall Details

Product Type
Drugs
Report Date
December 11, 2024
Initiation Date
November 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Product Description

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 230811, Exp: 08/11/2025