Sundial Herbal Products has recalled around 65 products, which were misbranded and currently unapproved drugs, the U.S. Food and Drug Administration said in a statement.
The recall follows an order by a federal judge in June to stop distributing the company’s unapproved new drugs.
The affected items include herbal products and dietary supplements. All Sundial Products distributed beginning January 1, 2014 through current period are being asked to recall, remove and return. These products’ labeling has drug claims stating they can diagnose, cure, mitigate, treat or prevent disease.
The products can be identified by the “Sundial” label with brown glass bottles, boxes, Ziploc bags and paper bags with clear viewing windows. They were distributed nationwide through the Sundial Herb website, or any other website or store pick up in their store location in Bronx, New York.
On May 27, U.S District Judge Edgardo Ramos in New York Court entered an order of permanent injunction against Rahsan Hakim and Adoniiah Rahsan, individuals doing business as Sundial Herbal Products. As per the complaint, Sundial continued to violate the law and distribute their products despite previous warnings from the FDA and repeated promises to correct violations.
Sundial said the recalled drug products with misleading labeling claims could result in a delay of appropriate treatment by a healthcare provider. The company has not received any reports of illnesses to date.
In similar incidents, Med Man Distribution in February had expanded its recall for dietary supplements for the potential undeclared presence of sildenafil.
Last year, Herbal Doctor Remedies called back all drug products that were sold without approval from the FDA.
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