FDA MedWatch - Americaine 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals

This notice is for Consumers, Health Professionals, and Pharmacy

ISSUE: Insight Pharmaceuticals is recalling one lot, 1A16420, of Americaine 20% Benzocaine Topical Anesthetic Spray. While benzene is not an ingredient in any Americaine 20% Benzocaine Topical Anesthetic Spray products, a recent review by the 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 lot code) are in the scope of this recall and may continue to be used by consumers safely and as intended.

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 exposure to it indoors and outdoors from multiple sources. 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The recalled product is used for minor cuts, scrapes, burns, and sunburns. 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.

RECOMMENDATIONS:

• 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.
• Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contact, or by phone at (800) 344-7239 to receive a full refund by providing a picture of the bottom of the can of the Americaine 20% Benzocaine Topical Anesthetic Spray with the affected lot code.
• Consumers who have the product that is being recalled should stop using the product immediately and appropriately discard it after taking a picture.
• Insight has notified retailers via overnight mail to remove any remaining recalled products from the shelves and to follow the instructions provided in the Drug Recall Notification.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.

This notice was updated by staf|The Los Angeles News