Multi-event May 2022 FDA Recall Drug by Amazon.com, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Amazon.com, Inc. on May 26, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1295-2022 TERMINATED D-1297-2022 TERMINATED D-1296-2022 TERMINATED

Recall Number: D-1295-2022

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Initiated
05-26-2022
Reported
07-27-2022
Quantity
2,441 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90627
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amazon.com, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-1297-2022

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Initiated
05-26-2022
Reported
07-27-2022
Quantity
15,087 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90627
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amazon.com, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Artri 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 B084KSV12L, UPC 7 501031 111190

Batch or Lot Expiration Information

Lot# : LTARTKNGOMG30720, Exp. Diciembre 2026 (December 2026)

Recall Number: D-1296-2022

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Initiated
05-26-2022
Reported
07-27-2022
Quantity
35,622 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90627
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amazon.com, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586

Batch or Lot Expiration Information

Lot# : 040 19, Exp. 09 FEB 2025