Botanical-Be Recalls Dietary Supplements Under Multiple Brands
El Paso, Texas-based Botanical-Be is recalling certain dietary supplements under multiple brands citing the presence of undeclared Diclofenac, the U.S. Food and Drug Administration said.
The recall involves all lots of Kuka Flex Forte, Artri King, and Reumo Flex capsules to the consumer level. These products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis.
Artri king was distributed in bottles with 100 capsules, Kuka Flex with 30 capsules, and Reumo flex with 30 capsules.
The affected Artri King comes with lot 35421 and an expiration date of December 19, 2025. The recall also includes all lots of Kuka Flex Forte with an expiration date of December 12, 2024, and UPC code 0736640810265; and all lots of Reumo Flex with an expiration date of October 20, 2024. These products were distributed across the United States through the internet.
As per the FDA analysis, all these products are tainted with Diclofenac, an approved non-steroidal anti-inflammatory drug or NSAID. The agency noted that 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. Therefore, these products are subject to recall.
Consumption of undeclared diclofenac may 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 underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.
However, Botanical-Be has not received any reports of adverse events related to the recalled products to date.
Consumers are urged to cease usage immediately and return them to the place of purchase.
In similar recalls, Brooklyn, New York-based WEFUN Inc. in September called back 300 boxes of dietary supplement capsules for undeclared Sildenafil, an ingredient known as a Phosphodiesterase Inhibitor or PDE-5 inhibitor found in FDA-approved products to treat male erectile dysfunction.
Inmar Supply Chain Solutions, LLC in late August recalled various FDA regulated products, including dietary supplements, stored at its Arlington, Texas Facility citing poor conditions including rodents and higher than required heat.
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