June 2022 FDA Recall Drug by Latin Foods Market
D-1284-2022 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Latin Foods Market on June 10, 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.

Recall Number: D-1284-2022

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Initiated
06-10-2022
Reported
07-20-2022
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90427
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.
Latin Foods Market
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot 334 21, Exp: 30 Nov, 2025