FOR IMMEDIATE RELEASE – November 7, 2023 – El Paso, TX. Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte, Capletas, Artri King, tablets and Reumo Flex, capleta at the consumer level. FDA analysis has found that Kuka Flex Forte Caplets, Reumo Flex and Artri King tablets are 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 makes them unapproved drugs for which safety and efficacy have not been established and therefore, subject to withdrawal.
Risk Statement: Undeclared consumption of diclofenac could result in serious adverse events including 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 medical conditions. underlying cardiovascular, gastrointestinal, renal and hepatic. To date, Botanical-Be has not received any reports of adverse events related to this recall.
These contaminated products are marketed as a dietary supplement for the relief of pain and inflammation associated with arthritis and are packaged as follows:
- Artri king is distributed in bottles with 100 tablets.
- Kuka Flex is distributed in bottles with 30 caplets.
- Reumo flex is distributed in 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 customers by email and arranging for the return of all recalled products. Consumers in possession of these products must immediately cease use and return them to the place of purchase.
For any questions related to this recall, consumers can contact Botanical-Be by phone at (915) 412-6237 or by email at [email protected] Monday through Friday from 8:00 a.m. to 5:00 p.m. :pm, Mountain Standard Time. Consumers should contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this pharmaceutical 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 the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on the form with the default address, or fax it to 1-800 -FDA-0178.
This recall is being made with the knowledge of the US Food and Drug Administration.
See the full recall here.
As published on: IntegrityPress.org