COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason Description
Elevated levels of lead
- Company Name:
- Handelnine Global Limited d/b/a Navafresh
- Brand Name:
- Product Description:
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Product Description
Company Announcement
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 test 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.
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. Product was distributed nationwide via our website www.navafresh.com.
Handelnine Global Limited is notifying its distributors and customers by email of the recalled product. 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.
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 on Monday to Friday from 10 am to 5 pm, GMT (UK time). 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
