ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapm
Summary
The FDA issued a Class I for ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2 by Boulla LLC. Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac..
Details
Source
Drug Recall
External ID
D-0086-2025
Action Date
2024-12-11
Status
Ongoing
Category
drug
Product Description
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Lot/Code Info: Lot #: YZM240406, Exp: 04/05/2027
Quantity Affected: Unknown
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-04
Company
Sacramento, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Boulla LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boulla LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boulla LLC have FDA actions?
Boulla LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0086-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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