Botanical-Be is voluntarily recalling of all lots of Kuka Flex Forte, Capsules, Artri King, Capsules, and Reumo Flex, Capsules to the consumer level. FDA analysis has found the Kuka Flex Forte, capsules, Artri King, capsules, and Reumo Flex, capsules, to be tainted 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.