Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO"
Summary
The FDA issued a Class I for Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mex by Latin Foods Market. Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone..
Details
Source
Drug Recall
External ID
D-1284-2022
Action Date
2022-07-20
Status
Terminated
Category
drug
Product Description
Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138
Lot/Code Info: Lot 334 21, Exp: 30 Nov, 2025
Quantity Affected: unknown
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-10
Company
San Jose, 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 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Latin Foods Market) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Latin Foods Market have FDA actions?
This is the only FDA action we have on record for Latin Foods Market in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1284-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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