Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Dietary Supplements
Reason for Announcement:

Recall Reason Description

Undeclared drug, Diclofenac

Company Name:
Botanical-Be
Brand Name:

Brand Name(s)

Product Description:

Product Description

Dietary Supplements with undeclared Diclofenac

Company Announcement

FOR IMMEDIATE RELEASE – November 7, 2023 – In El Paso, TX, Botanical-Be has voluntarily initiated a recall of all batches of Kuka Flex Forte caplets, Reumo Flex caplets, and Artri King tablets. This recall is directed at the consumer level. The FDA’s analysis revealed that the Kuka Flex Forte caplets, Artri King tablets, and Reumo Flex caplets have been contaminated with Diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), the presence of Diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses. To date, Botanical-Be has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and are packaged as followed:

  • Artri king distribute in the bottles with 100 tablets.
  • Kuka Flex distribute in the bottles with 30 caplets.
  • Reumo flex distribute in the boxes with 30 caplets.

The affected product lots include the following lot numbers and expirations: Artri King lot 35421, with an expiration date of December 19, 2025; Kuka Flex Forte; all lots with an expiration date of December 12, 2024, and UPC code 0736640810265; Reumo Flex; all lots with an expiration date of October 20, 2024. These products were distributed nationwide via the internet.

Botanical-Be is notifying its customers via email and is arranging for the return of all recalled products. Consumers in possession of these products should cease usage immediately and return them to the place of purchase.

For any queries related to this recall, consumers can contact Botanical-Be by phone at ‪(915) 412-6237‬ or by e-mail at botanical.be@gmail.com on Monday to Friday from 8:00 am to 5:pm, Mountain standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Spanish Translation