Recall notice
Virgo Rheumacare Capsules recalled due to Elevated levels of lead, USA
3 weeks ago •source fda.gov
United States
Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In tests conducted by the Food and Drug Administration, the product has been found to contain lead at levels up to 11,100 ppm, which are higher than permissible levels. The product was distributed nationwide in the United States via the Navafresh website.Risk Statement: 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. To date, Handelnine Global Limited has received one adverse event complaint related to this recall.
The product is used to reduce joint pain and is packaged in white plastic containers bearing the label of the brand Rheumacare Capsules. The affected Rheumacare Capsules lots include the following CAM040 & CALO79-N.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/handelnine-global-limited-dba-navafresh-issues-nationwide-recall-rheumacare-capsules-virgo-uap
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