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| The United States: Insight Pharmaceuticals issues voluntary nationwide recall of Americaine® 20% Benzocaine Topical Anesthetic Spray due to the presence of benzene (English only) |
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The US Food and Drug Administration (FDA) announces that Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray (lot number: 1A16420) to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended.
Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-americainer-20-benzocaine-topical
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, Dec 23, 2023
Issued at HKT 12:00
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