Multi-event May 2022 FDA Recall Drug by Walmart Inc
This Multi-event Class I drug recall was voluntarily initiated by Walmart Inc on May 24, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an unapproved nda/anda. The product was distributed Nationwide and the recall is currently completed.
Reported Recall Events
Recall Number: D-1157-2022
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
05-24-2022
06-22-2022
1308 bottles total
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Walmart Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
Batch or Lot Expiration Information
Lot# Lot: LTARTKNGOMG30720, Exp Diciembre 2026
Recall Number: D-1159-2022
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
05-24-2022
06-22-2022
1308 bottles total
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Walmart Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
Batch or Lot Expiration Information
Lot# All product lots.
Recall Number: D-1158-2022
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
05-24-2022
06-22-2022
1308 bottles total
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Walmart Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.
Batch or Lot Expiration Information
Lot# All product lots.
