TOPIC: Rheumacare Capsules by Handelnine Global Limited d/b/a as Navafresh: Recall - Due to Elevated Lead Levels
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Rheumatology
ISSUE: Handelnine Global Limited d/b/a Navafresh is recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) because in test conducted by the FDA the product has been found to contain lead at levels up to 11,100 ppm, which are higher than permissible levels.
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.
The affected Rheumacare Capsules lots include the following CAM040 & CALO79-N. Product was distributed nationwide via website www.navafresh.com.
To date, Handelnine Global Limited has received one adverse event complaint related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used to reduce joint pain and is packaged in white plastic containers bearing the label of the brand Rheumacare Capsules.
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 that have product which is being recalled should stop using and discard the product immediately. A refund shall be issued to consumers who had placed orders for the product with us.
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Consumers with questions regarding this recall can contact Mr. Ankit Mota at Handelnine Global Limited by phone number +1 442-223-0999 or e-mail address legal@handelnine.com.
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