Handelnine Global Limited, operating as Navafresh, has issued a nationwide recall of two lots of Rheumacare Capsules produced by Virgo UAP Pharma Pvt. Ltd. The decision follows testing by the U.S. Food and Drug Administration (FDA) that identified lead levels in the product reaching up to 11,100 parts per million, which exceeds permissible safety limits.
According to Handelnine Global Limited, “the product potentially could result in public health risk. Sustained exposure of elevated levels of lead poses increased potential toxicological risks to consumers to include cognitive impairment, depression, nausea and abdominal pain, motor incoordination, and peripheral neuropathy (loss of muscle control). Prolonged exposure has also been linked to the development of anemia. From a reproductive health standpoint, chronic lead exposure has been correlated with increased risk of miscarriage in females and reduced fertility in males. Acute toxicity of lead poisoning could lead to abdominal pain/colic, vomiting, constipation, peripheral neuropathy, and cerebral edema and encephalopathy, which can lead to seizures, coma, and death.” The company noted it has received one adverse event complaint related to this recall.
Rheumacare Capsules are marketed for joint pain relief and were distributed nationwide through the website www.navafresh.com. The affected lot numbers are CAM040 and CALO79-N.
The company is notifying distributors and customers by email about the recall. Consumers are advised to stop using the recalled capsules immediately and discard them. Refunds will be provided for those who purchased the affected product.
Customers with questions can contact Mr. Ankit Mota at Handelnine Global Limited via phone at +1 442-223-0999 or email legal@handelnine.com during business hours from Monday through Friday.
Adverse reactions or quality issues connected with Rheumacare Capsules can be reported directly to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by downloading forms from www.fda.gov/MedWatch/getforms.htm.
Handelnine Global Limited stated that “this recall is being conducted with the knowledge of the U.S. Food and Drug Administration.”
