Class I — Most Severe

Rheumacare Capsules Recalled for High Lead Levels

FreshRecall Team Handelnine Global Limited d/b/a Navafresh Lead Contamination

This recall was posted 3 months ago. Check the FDA source for the latest status.

Class I Recall — Most Serious

This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.

Virgo brand Rheumacare Capsule, 20 capsules

Handelnine Global Limited, operating as Navafresh, has announced a nationwide recall of Rheumacare Capsules due to elevated lead levels. The recall affects specific lots of the product, which were found to contain lead at levels up to 11,100 ppm, exceeding permissible limits.

Affected Products:

  • Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd.
  • Lot Numbers: CAM040 & CALO79-N
  • Packaged in white plastic containers with the Rheumacare label

Reason for Recall:

The recall was initiated after FDA tests revealed high lead levels in the capsules. Prolonged exposure to lead can pose serious health risks, including cognitive impairment, depression, nausea, and abdominal pain. It may also lead to more severe conditions such as anemia, reproductive health issues, and in acute cases, seizures, coma, or death.

Consumer Guidance:

Consumers are advised to immediately stop using the affected Rheumacare Capsules and discard them. A refund will be provided to those who purchased the product. For questions, consumers can contact Mr. Ankit Mota at Handelnine Global Limited by phone at +1 442-223-0999 or email at [email protected], Monday to Friday, 10 am to 5 pm GMT.

Consumers who have experienced any adverse effects should consult their healthcare provider and report any reactions to the FDA’s MedWatch Adverse Event Reporting program.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Where Products Were Sold

This recall affects products distributed nationwide across the United States.

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View original FDA announcement