Insight Pharmaceuticals Voluntarily Recalls Americaine® 20% Benzocaine Topical Anesthetic Spray Nationwide Due to Benzene Contamination, FDA Alert
Insight Pharmaceuticals, a leading pharmaceutical company, has issued a voluntary recall of its popular product, Americaine® 20% Benzocaine Topical Anesthetic Spray, across the United States. The recall comes in response to a recent alert from the U.S. Food and Drug Administration (FDA) regarding potential benzene contamination in the product.
Benzene is a known carcinogen that can cause serious health issues when consumed or exposed to in high amounts. The FDA has set strict limits on the acceptable levels of benzene in consumer products, including pharmaceuticals. In this case, the agency found that certain batches of Americaine® 20% Benzocaine Topical Anesthetic Spray contained higher levels of benzene than the approved limit.
The affected product is commonly used for temporary relief of pain and itching associated with minor cuts, scrapes, burns, insect bites, and other skin irritations. It is available over-the-counter and widely used by consumers across the country. Insight Pharmaceuticals has taken immediate action to remove the affected batches from store shelves and is working closely with the FDA to investigate the source of the contamination.
Consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray are advised to stop using it immediately and return it to the place of purchase for a full refund. The company has also set up a dedicated hotline for customers to address any concerns or questions related to the recall.
While there have been no reports of adverse effects related to the recalled product so far, the FDA urges consumers to be cautious and seek medical attention if they experience any unusual symptoms after using Americaine® 20% Benzocaine Topical Anesthetic Spray. Symptoms of benzene exposure can include dizziness, rapid or irregular heartbeat, headache, tremors, confusion, and even unconsciousness.
Insight Pharmaceuticals is committed to ensuring the safety and well-being of its customers and is working diligently to rectify the situation. The company is conducting a thorough investigation to identify the root cause of the benzene contamination and implementing measures to prevent such incidents in the future.
The FDA is closely monitoring the recall process and will continue to provide updates to the public as more information becomes available. The agency advises consumers to always check for FDA alerts and recalls before using any over-the-counter medications or healthcare products.
In conclusion, Insight Pharmaceuticals’ voluntary recall of Americaine® 20% Benzocaine Topical Anesthetic Spray nationwide due to benzene contamination highlights the importance of rigorous quality control measures in the pharmaceutical industry. Consumers are urged to follow the FDA’s guidance and return the affected product for a refund. The FDA will continue to work with Insight Pharmaceuticals to ensure the safety of consumers and prevent any potential harm from contaminated products.
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- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/fda-alert-insight-pharmaceuticals-issues-voluntary-nationwide-recall-of-americaine-20-benzocaine-topical-anesthetic-spray-due-to-the-presence-of-benzene/