ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacrame...
FDA Recall #D-0086-2025 — Class I — November 4, 2024
Product Description
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recalling Firm
Boulla LLC — Sacramento, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
Unknown
Distribution
Nationwide within the United States
Code Information
Lot #: YZM240406, Exp: 04/05/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated