FDA orders recall of Arcan Bitters over undeclared drug substance
The Food and Drugs Authority (FDA) has ordered the recall of Arcan Bitters from the market after laboratory tests found that the product had been adulterated with Sildenafil Citrate. The Authority has directed Unni Associates Company Limited, the manufacturer of the product, to recall all Arcan Bitters from the market within 14 days. The FDA … The post FDA orders recall of Arcan Bitters over…
The Food and Drugs Authority (FDA) has mandated the withdrawal of Arcan Bitters from the market following the discovery of Sildenafil Citrate, a prescription-only drug, in the product during laboratory tests. The Authority has given Unni Associates Company Limited, the manufacturer, 14 days to recall all Arcan Bitters from the market.
The FDA announced the closure of the company’s factory in the Ashanti Region where the product is manufactured. The product, registered as a food item and alcoholic drink, should not contain any drug substances. The presence of Sildenafil Citrate poses severe health risks, potentially leading to stroke or heart attack, and long-term health issues such as loss of vision and hearing.
Adulterating food products is punishable under the Public Health Act. The FDA warns that non-compliance could lead to further sanctions, including criminal prosecution. The agency will oversee the safe disposal of all recalled products and urges the public to report any sellers of the product to local FDA offices for its complete removal.
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