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Class I: serious health riskTerminated

Amazon.com Artri Ajo King Reforzado con Ortiga y Omega Recall

Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho…

Amazon.com, Inc. · Seattle, WA

Risk level
Class I
Reported by FDA
Jul 27, 2022
Recall ID
D-1295-2022
Check your lot numberHow we source this data

Summary

Amazon.com recalled Artri Ajo King Reforzado con Ortiga y Omega starting May 26, 2022. The FDA classified it as Class I (serious health risk) and published enforcement report D-1295-2022 on Jul 27, 2022. Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

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 numbers, UPCs & expiration codes

Lot #: LTARTKNGOMG30220, Exp. Diciembre 2025 (December 2025).

Where it was sold

Nationwide within the U.S.A.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1295-2022
Classification
Class I
Status
Terminated
Recall initiated
May 26, 2022
FDA report date
Jul 27, 2022
Quantity
2,441 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Amazon.com, Inc.

Original FDA data

Every field from FDA enforcement report D-1295-2022, exactly as published.

Show all FDA fields
City
Seattle
State
WA
Status
Terminated
Country
United States
Event ID
90627
Address
2021 7th Ave
Code information
Lot #: LTARTKNGOMG30220, Exp. Diciembre 2025 (December 2025).
Postal code
98121-2601
Report date
Jul 27, 2022
Product type
Drugs
Recall number
D-1295-2022
Classification
Class I
Recalling firm
Amazon.com, Inc.
Product quantity
2,441 bottles
Termination date
Nov 8, 2022
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide within the U.S.A.
Recall initiation date
May 26, 2022
Initial firm notification
E-Mail
Center classification date
Jul 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1295-2022, published Jul 27, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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