Multi-event October 2023 FDA Recall Drug by Botanical Be
This Multi-event Class I drug recall was voluntarily initiated by Botanical Be on October 20, 2023 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 ongoing.
Reported Recall Events
Recall Number: D-0225-2024
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
10-20-2023
12-06-2023
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Botanical Be
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
Batch or Lot Expiration Information
Lot# All lots, exp 10/20/2024
Recall Number: D-0224-2024
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
10-20-2023
12-06-2023
235 bottles
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Botanical Be
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
Batch or Lot Expiration Information
Lot# Lot 35421, exp 12/19/2025
Recall Number: D-0226-2024
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
10-20-2023
12-06-2023
300 bottles
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Botanical Be
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Batch or Lot Expiration Information
Lot# All lots, exp 12/12/2024
