Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de
Summary
The FDA issued a Class I for Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, by Botanical Be. Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac..
Details
Source
Drug Recall
External ID
D-0224-2024
Action Date
2023-12-06
Status
Ongoing
Category
drug
Product Description
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
Lot/Code Info: Lot 35421, exp 12/19/2025
Quantity Affected: 235 bottles
Reason for Recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
El Paso, TX
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 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Botanical Be has 3 FDA actions in our database, including 3 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 (Botanical Be) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Botanical Be have FDA actions?
Botanical Be has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0224-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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