Safety Report: Americaine Benzocaine Topical Anesthetic Spray - recalled due to Presence of benzene, USA

United States

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray 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. The affected Americaine® 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online. To date, the Company has not received any serious adverse events related to this recall.

Risk Statement: 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. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can. Samples of the recalled lot below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products.

- Product: Americaine® 20% Benzocaine Topical Anesthetic Spray, NDC: 63736-378-02, Lot Code: 1A16420, Expiration: 01/25, Package Size: 2oz/57g.

Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray marked with the lot code in the table above.

Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this anesthetic product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Insight Pharmaceuticals
Brand name: Americaine
Product recalled: Benzocaine Topical Anesthetic Spray
Reason of the recall: Presence of benzene
FDA Recall date: December 22, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-americainer-20-benzocaine-topical