被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Botanical-Be issues voluntary nationwide recall of Kuka Flex Forte, Artri King and Reumo Flex capsules due to presence of undeclared diclofenac (English only) |
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The US Food and Drug Administration (FDA) announces that Botanical-Be is voluntarily recalling of all lots of Kuka Flex Forte, Artri King and Reumo Flex capsules to the consumer level. FDA analysis has found the Kuka Flex Forte, Artri King and Reumo Flex capsules to be tainted with diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), the presence of diclofenac in these products renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/botanical-be-issues-voluntary-nationwide-recall-kuka-flex-forte-artri-king-and-reumo-flex-capsules
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 3 Oct 2023.
Ends/Tuesday, Oct 24, 2023
Issued at HKT 15:30
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