Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINAL
Summary
The FDA issued a Class I for Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, by Amazon.com, Inc.. Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac..
Details
Source
Drug Recall
External ID
D-1295-2022
Action Date
2022-07-27
Status
Terminated
Category
drug
Product Description
Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190
Lot/Code Info: Lot #: LTARTKNGOMG30220, Exp. Diciembre 2025 (December 2025).
Quantity Affected: 2,441 bottles
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Distribution
Nationwide within the U.S.A.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-26
Company
Seattle, WA
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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amazon.com, Inc. 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 (Amazon.com, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amazon.com, Inc. have FDA actions?
Amazon.com, Inc. 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-1295-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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