Botanical-Be is recalling all lots of three dietary supplements because they contain undeclared Diclofenac, which is an approved non-steroidal anti-inflammatory drug. The presence of this drug in the supplements Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established. The firm has not received any reports of adverse reactions to date. The recalling firm is Botanical-Be of El Paso, Texas.
The risk statement from the FDA reads: 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.
These products are marketed for relief of inflammation and pain associated with arthritis. They include Artri King that is sold in bottles of 100 capsules each. The lot number is 35421, and the expiration date is December 19, 2025. Kuka Flex Forte, distributed in bottles with 30 capsules each, is also recalled; all lot numbers are included in this recall. The expiration date is December 12, 2024, and the UPC number is 0736640810265. Finally, Reumo Flex that is distributed in boxes with 30 capsules each is recalled. All lots of that product are recalled, and they have the expiration date of October 20, 2024. All of these items were sold nationwide over the internet. You can see pictures of these products at the FDA web site.
.If you bought any of these dietary supplements, do not use them. You can contact the company to arrange for a return. Contact your physician if you have experienced any adverse health effects. You can report adverse events to the FDA through the FDA MedWatch Adverse Event Reporting System.
