Handelnine Global Limited, doing business as Navafresh, has recalled two lots of its Rheumacare capsules because they contain too much lead.
The capsules by Virgo UAP Pharma were sold nationwide online at www.navafresh.com.
The recalled lots are CAM040 and CALO79-N, according to the U.S. Food and Drug Administration.
“In a 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,” according to an announcement with the FDA.
The FDA issued a warning letter to Handelnine in November about a number of its products saying they are “unapproved new drugs.” That list included Rheumacare capsules.
The FDA said the presence of lead at these levels raises significant safety concerns and shows the product wasn’t manufactured properly.
According to the label, the FDA said the medication “is the combination of non-steroidal anti-inflammatory, analgesic and disease modifying drugs. Rheumacare is very effective to treat all type [sic] of arthritic conditions.”
Sustained exposure to elevated levels of lead can lead to cognitive impairment, depression, nausea and abdominal pain, motor incoordination and 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.”
Handelnine Global Limited said it has received one “adverse event complaint” related to the recall.
The company said it is notifying its distributors and customers by email about the recall.
People who purchased the capsules should stop using them and discard them. Refunds will be issued.
For more information, call Ankit Mota at +1 422-223-0999, between 5 a.m. and noon ET, Monday through Friday, or send an email to legal@handelnine.com.