TOPIC: Kuka Flex Forte, Artri King, and Reumo Flex (Capsules) by Botanical - Be: Recall - Due to Presence of Undeclared Diclofenac
AUDIENCE: Consumer, Health Professional, Rheumatology
ISSUE: Botanical-Be is recalling of all lots of Kuka Flex Forte, Capsules, Artri King, Capsules, and Reumo Flex, capsules because 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.
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.
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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis.
RECOMMENDATIONS:
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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.
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Consumers in possession of these products should cease usage immediately and return them to the place of purchase.
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For any queries related to this recall, consumers can contact Botanical-Be.
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