On Monday, the U.S. Food & Drug Administration announced the recall of a consumer joint-pain supplement after testing found lead levels above permissible limits.
Recall Details
Handelnine Global Limited, doing business as Navafresh, has pulled two lots of its Rheumacare capsules-CAM040 and CALO79-N-from the market. The product was sold nationwide through the company’s website, www.navafresh.com.
FDA Findings
The FDA stated that “higher than permissible levels” of lead were detected. It added that “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),” according to the FDA.
Prior Warning
Earlier in November, the FDA sent a warning letter to Handelnine, noting that several of its products are classified as “unapproved new drugs.” Rheumacare was highlighted because the lead levels raised significant safety concerns.
Consumer Guidance
So far, Handelnine has received one adverse-event complaint linked to the recalled product. Consumers are advised to dispose of any Rheumacare capsules immediately. For questions, they can call +1 442-223-0999 or email [email protected] from Monday to Friday, 10 a.m. to 5 p.m. GMT.
Key Takeaways
- FDA recalls Navafresh’s Rheumacare capsules after lead levels exceed limits.
- One adverse event has been reported.
- Consumers should discard the product and contact the company for assistance.
The recall underscores the importance of strict quality control for dietary supplements and the FDA’s role in protecting public health.
